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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Thyroid Problems (2102); Urinary Retention (2119); Weakness (2145); Stenosis (2263); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(b)(6).(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
 
Event Description
It was reported that (b)(6) 2006 patient presented with a complaint of abdominal pain and patient states pain to left lower abdomen.Patient also with severe low back pain that radiates down both legs.Patient with urinary incontinence for 1 week.The onset was gradual.The course was constant.The location of pain upon onset was the left lower quadrant.The present location of pain was the left lower quadrant.The quality was moderate.The exacerbating factor was negative.The mitigating factor was analgesics.The risk factor was negative.(b)(6) 2006 patient presented with pre op diagnosis: 1.Low back pain 2.Possible spinal cord compression.Operation/procedure: 1 -l2 laminectomy.Patient had low back pain with possible numbness and weakness.(b)(6) 2006 patient presented with preop and postop diagnosis of instability at l1-l2.The patient underwent following procedures: 1.Arthrodesis at l1-l2.2.Diskectomy at l1-l2.3.Biomechanical cage fusion at l1-l2 with bmp.4.Spinal plate fixation from l1-l2 to l2 5.Excision of spinal nerve root tumor and microscopic dissection.Complications: dural tear which was primarily repaired.Condition: stable; the patient was transported to the pacu postoperatively.Findings: nerve root tumor on the left side at l1 approximately five times bigger than the diameter of the nerve root and approximately one- quarter inch in diameter.Note the nerve root was also folded back on itself and the surgeon put a diaphragm in my postop documentation, and there was severe constriction of the nerve root.Indications: the attending physician was dr.(b)(6) although the patient was admitted to (b)(6).The patient was admitted on (b)(6) 2006, with severe left quadrant pain and worked up with cardiac and abdominal workup which was negative.An mri of the lumbar spine demonstrated severe degenerative changes at the l1-l2 level which was her symptomatic level.It was decided that it appeared to be unstable at that level and needed decompression.The patient understood the risks and benefits of surgery and gave her permission for surgery.Specimens: tumor.Drains: none.Op note: a teak biomechanical cage was placed that had been packed with bmp bone morphogenetic protein.It was packed with the attempt to get it at a t lift across the midline.There was inability to get this across midline, so at this time it was decided to do the laminotomy on the opposite side.Laminotomy was done on the right side, again identifying the disk space.The disk space was then excised.The l1 nerve root was carefully retracted out of the way and a second biomechanical cage was placed on the right side at l1 and l2.At this time, was copiously irrigated.The patient was transported to the recovery room in good condition.There were no complications intraoperatively other than the dural tear which was identified.(b)(6) 2006 patient presented x-ray for chest pain.Impression: 1.Heart size was normal to borderline enlarged.2.Prominent pulmonary vasculature, likely due to poor inspiratory effort versus effects of portable technique.However, early pulmonary venous hypertension cannot entirely be ruled out.Recommend follow up chest pa/lateral.(b)(6) 2006 patient presented for chest pa and lateral.Impression: 1.Lungs expanded.2.Pulmonary vascularity had returned to normal limits.3.On lateral film, there was a radiopaque density seen posteriorly in the upper lumbar area.This might be something external to the patient or in the patient.There were no earlier films for comparison.On the pa view, there appear to be densities overlying the l2 region.Again, correlation was requested as to whether the patient might have had surgery to the spine.(b)(6) 06 patient was discharged from hospital.(b)(6) 2007 patient presented for ct scan abdomen and pelvis with iv and oral contrast diverticulitis.Impression: minimal free pelvic fluid, likely physiologic, no acute intra-abdominal or pelvic pathology.(b)(6) 2007 patient presented for mri - mild enhancement of end plates of l1-l2 vertebrae likely post surgical; posterior osteophytes at l1-l2 causing canal narrowing.Mri of the thoracic spine mild degenerative disc disease as described above.Hemangiomas at c7, t5 and t9 vertebrae.Mri of the lumbar spine.Postoperative changes as described.Mild enhancement of the end plates of l1-l2 vertebrae on post contrast images, likely post-surgical.Recommend clinical correlation.Posterior osteophytes at l 1-l2 causing mild spinal canal narrowing.Degenerative disc disease at l4-l5 and l5-s1 levels as described.(b)(6) 2007 patient presented for x-ray with back pain.Impression: unremarkable study.(b)(6) 2007 mri - left l1-l2 foraminal obliteration with enhancing fibrosis type tissue; l4-l5 disc bulge.Patient presented for back pain.Impression: 1 l1-l2 fusion.Disc bulge unchanged.No central stenosis.2.Left l1-l2 foraminal obliteration with enhancing fibrosis type tissue.No change.3.L4-l5 disc bulge unchanged.No stenosis.4.L5-s1 annular tear unchanged.5.No infection.Mri lumbar spine: clinical info: bladder incontinence with lower extremity weakness and pain.Findings: l1-l2: prior anterior effusion with disc spacers.Moderate diffuse disc bulge similar to (b)(6) 2007 scan.Soft tissue filled the left l1-l2 foramen as before which shows some enhancement consistent with fibrosis.No interval change.No central stenosis.L2-l3: disc level was unremarkable, other than posterior fusion at l2-l3.L3-l4: disc level was unremarkable, other than posterior fusion at l2-l3.L4-l5: moderate broad base disc bulge similar to (b)(6) 2007.No foraminal stenosis.(b)(6) 2007 patient was presented with preop and postop diagnosis: instability of l5 - s1 with back pain and degenerative disk disease.Post laminectomy syndrome.He underwent operation/procedure: 1.Anterior lumbar interbody fusion on l5-s1, biomechanical implant, and bone morphogenic protein.Op note: a 12mm implant was placed and slightly countersunk; it had been previously filled with bone morphogenic protein sponge.Next, a 23 mm pyramid plate was placed bridging l5 to s1.Screws were engaged after all had been used to penetrate the bone in each location.Once screws were secured in place, a manhole cover was placed over screw heads.X-ray confirmed excellent position both in the ap and the lateral plane, and the disk had been restored to a more normal height with distraction of the interbody spacer.Hemostasis was obtained and the wound was closed in anatomic layers.Impression: free intraperitoneal air loculi.In the absence of recent surgery or intervention, this may represent hollow viscus perforation, the exact site was unclear.Fluid filled colon to the level of rectum, which may represent ileus.Recommend clinical correlation.(b)(6) 2007 patient was presented for abd-w/wo, pelvis-w, lumbosacral instability (b)(6) 2007 patient was discharged.(b)(6) 2009 patient was presented with low back pain with associated urinary bladder and bowel incontinence.Musculoskeletal: she moved all extremities, right greater than left.She had severely positive straight leg raise sign at 15 degrees on the left.She had pain with internal and external rotation of the left lower extremity in the hip.Musculoskeletal strength was noted to be 5/5 in plantar flexion, dorsiflexion, extensor hallucis longus, knee extensors and quadriceps at the right lower extremity and what i would grade as 3-4/5 in the quadriceps of the left lower extremity.Neurologic: her sensation was grossly intact to light touch in the lower extremities.However, she does have decreased sensation in the left anterior thigh into the groin with decreased rectal tone.Deep tendon reflexes arc noted to be 3+ throughout.Mri scan of lumbar spine.There were no acute disk herniations or fractures.The spinal canal was widely patent and there was no cauda equina compression.Impression: i.Low back pain with radiation into groin, status post fall.2.Decreased sensation in groin and anterior thigh 3.Urinary and bladder incontinence, unknown source, unable to determine cause of the patient incontinence based on radiographic studies.There was no cauda equine compression which cannot explain her current symptoms.4.Left lower extremity pain with internal and external rotation.5.Questionable neurogenic bladder.(b)(6) 2010 ct l-spine - narrowing of disc space with marginal hypertrophic spurs and vacuum phenomena at l1-l2 and l2-l3 levels.(b)(6) 2010 findings: the perianal exam was abnormal.Findings include hemorrhoids.External and internal hemorrhoids were found during retroflexion and ware mild.Impression: hemorrhoids, external and internal hemorrhoids, the hepatic flexure, ascending colon and cecum are normal, the descending colon, splenic flexure and transverse colon are normal, the descending colon was normal.Epigastric abdominal pain.No immediate complications.Findings: the examined esophagus was normal.Biopsies were taken with a cold forceps for histology.Estimated blood loss was minimal.The z-line was regular and was found 39 cm from the incisors.Localized moderately erythematous mucosa with no bleeding was found in the gastric antrum.Biopsies were taken with a cold forceps for histology.Estimated blood loss was minimal.Impression: normal esophagus, this was biopsied, z-line regular, 39 cm from the incisors, gastric mucosal abnormality characterized by erythema.Biopsied, normal cardia, gastric fundus and gastric body, normal duodenal bulb and 2nd part of the duodenum.Indications: hemorrhoids, external and internal hemorrhoids.Heniatocliezla, melena for the procedure: colonoscopy.Findings: the perianal exam was abnormal.Findings include hemorrhoids.External and internal hemorrhoids were found during retro flexion and were mild.(b)(6) 2010 imaging studies: her mri reveals she had severe spondylotic hard disc disease at c 5-6 with endplate changes and bone on bone.Effacement of subarachnoid space also noted.She also had moderate spondylosis with endplate changes at c 6-7.Assessment: cervical disk with radiculopathy.(b)(6) 2010 chest pa and lateral: history: smoker.History of ovarian cancer.Preop.Postoperative changes present in the spine.Cardiac silhouette and mediastinum are within normal limits and the lungs show no infiltrate or edema and no effusion.Impression: no evidence of acute cardiopulmonary disease.(b)(6) 2010 patient presented with neck pain radiated to both shoulders, worse on the right, with pain in the right arm and hand.She had numbness and tingling in both hands, and she was losing strength in her right grip.She had had cervical conservative therapy with epidural steroid injections, cervical catheter, and pain pump with dr.(b)(6) without much improvement.Neurologic: the patient had pain along her c6 dermatome.Motor exam was normal with 5/5 strength in deltoids, biceps, triceps, and grip.Sensory exam was also normal throughout her bilateral upper extremities.Tendon reflexes were also noted to be normal.Her mri revealed that severe spondylitic hard disk disease at c5-c6 with endplate changes and bone-on-bone with effacement of subarachnoid space as well.She also had moderate spondylosis with endplate changes at c6-c7.Assessment: cervical disk with radiculopathy.Patient presented with preop and postop diagnosis of cervical disk with radiculopathy and underwent the following procedures: 1.Anterior cervical diskectomy c5-c6.2.Anterior arthrodesis c5-c6.3.Anterior plate instrumentation (strker c5-c6).4.Placement of peek allograft anterior intervertebral cage implants c5-c6.5.Utilization of intraoperative microscope for microdissection.Op report - acdf c5-6 using viotoss.No complication was reported.Cervical spine film: lateral view of the spine obtained intraoperatively for localization demonstrates a ball-tipped probe in the anterior aspect of c5-6 disc space.Intervertebral material.No complications.Lateral view of cervical spine in the operating room: patient had had anterior cervical fusion of c5-c6 level with intervertebral material, anterior plate and screws.No complication was reported.There was good alignment of c5-c6.(b)(6) 2010 the patient presented with neurosurgical clinic.Imaging studies: she was to have a plain x-ray of her cervical spine.Assessment: cervical disc with radiculopathy.(b)(6) 2011 patient was presented for abdomen portable.Impression: 1.No residual barium.2.Nonspecific bowel gas pattern.(b)(6) 2011 mri of the c-spine.Indication: neck and left shoulder pain.Findings: anterior metallic plate fusion across c5-6 level.Some mild straightening through the cervical spine but no significant subluxation suggested.The cervical cord was normal in caliber and contour with no abnormal signal or syriruc.No cerebellar tonsillar ectopia.Small hemangioma in the c7 vertebral body noted incidentally.No compression deformities or fractures.C5-6 level demonstrates a fairly prominent area of likely right neural foraminal disc protrusion and spur complex but i presume this was not significant as the patient's pain was reportedly just on the left.This produces at least moderate right neural foraminal narrowing with no significant central canal stenosis and there was no significant left neural foraminal narrowing at this level.(b)(6) 2011 patient presented for mri of the c-spine.Indication: neck and left shoulder pain.Findings: anterior metallic plate fusion across c5-6 level.Some mild straightening through the cervical spine but no significant subluxation suggested.The cervical cord was normal in caliber and contour with no abnormal signal or syrinx.No cerebellar tonsillar ectopia.Small hemangioma in the c7 vertebral body noted incidentally.No compression deformities or fractures.C5-6 level demonstrates a fairly prominent area of likely right neural foraminal disc protrusion and spur complex but i presume this was not significant as the patient's pain was reportedly just on the left.This produces at least moderate right neural foraminal narrowing with no significant central canal stenosis and there was no significant left neural foraminal narrowing at this level.Impression: 1.Anterior metallic plate fusion c5-6.Some straightening through the cervical spine with no abnormal signal in the cord.2.No definite findings to suggest nerve impingement or severe stenosis or any findings to explain the patient's left-sided radiculopathy symptoms, see above regarding the right side at c5-6.3.Not mentioned above, there my be a small cystic area in the posterior left lobe of the thyroid that can be evaluated with thyroid ultrasound as needed and this measures just over 1 cm.(b)(6) 2011 indication: patient presented with abdominal pain.Findings: right subclavian central line was noted with the tip at the atriocaval junction.No pleural effusion or pneumothorax was seen.No consolidation was seen.No pulmonary nodules are noted.Impression: 1.No acute cardiopulmonary disease was identified.2.Right subclavian central line was noted with tip at the atriocaval junction.No pneumothorax was seen.(b)(6) 2011 indication: patient presented with abdominal pain.Conclusion: normal hepatobiliary scan with gallbladder ejection fraction 54.7%.Patient presented for right upper quadrant ultrasound.Findings: transabdominal sonographic images demonstrate portions of the pancreas to be obscured by overlying bowel gas.Visualized portions of the liver appear unremarkable.There are no focal hepatic mass lesions.There was no evidence for intrahepatic ductal dilation.Common bile duct size was within normal limits at 3 mm.The gallbladder appears normal with no sludge, stones, or polyp.There was no abnormal pericholecystic fluid or gallbladder wall thickening.Right kidney measures 9.6 cm in length.There was no hydronephrosis or abnormal perirenal fluid collections.Conclusion: 1.Unremarkable right upper quadrant ultrasound.2.Portions of the pancreas obscured by overlying bowel gas.(b)(6) 2011 patient presented ct of the abdomen and pelvis.Indications: history of cervical cancer and abdominal pain.Findings: there was linear atelectasis seen within the postero-inferior lung bases.The liver, spleen, adrenals, and kidneys appear unremarkable.Pancreas appears within normal limits.There was no free fluid or lymphadenopathy seen within the abdomen.There was a 3.8 cm cyst noted within the left ovary, which appears relatively simple.The appendix was not clearly identified, but there are no secondary signs to indicate acute appendicitis.Postsurgical changes are noted in the lumbar spine.There are no lytic or blastic osseous lesions identified.Conclusion: 1.Simple-appearing 3.8 cm cyst noted in the left ovary.In a premenopausal patient, this was likely benign.2.Incidental note was made of a retroaortic left renal vein not mentioned above.3.Postsurgical changes noted in the lumbar spine.4.The appendix was not clearly identified, but there are no secondary signs to indicate acute appendicitis.5.Uterus was surgically absent.(b)(6) 2011 gallbladder ultrasound: transabdominal images demonstrate no focal lesions of the liver, gallbladder, or biliary tree.The right kidney was free of hydronephrosis.Common bile duct was normal measuring less than 3 mm.No gross abnormalities of the pancreatic bed.Impression: negative gallbladder ultrasound.(b)(6) 2011 it was reported findings: right sided central venous line tip in svc, satisfactory position.Normal heart size.Clear lungs.No evidence of pneumothorax.Impression: central venous line in satisfactory position.(b)(6) 2011 ct of the chest with pulmonary embolism protocol.Findings: the pulmonary arteries were well opacified and free of filling defects or abrupt vessel cutoff.Small dependent pleural effusions are noted.Small amount of fluid was present within the major fissure on the left.No discrete infiltrate was evident.No mediastinal nor hilar larynphadenopathy was evident.A tiny prevascular node was present.Impression: 1.No central pulmonary emboli.2.Small dependent effusions without evidence, at this time, for acute congestive failure.Ct of the abdomen-enhanced: history: abdominal pain.Findings: surgical clips occupy the gallbladder fossa.The liver and spleen are free of defects.Pancreatic contours are normal.The adrenal glands and kidneys are unremarkable.There was no evidence for hydronephrosis.The infrarenal aorta was of normal caliber.There are several tiny locules of free air situated immediately cephalad to the mid-transverse colon.A discrete obstructing colonic mass was not discernible although there do appear to be several diverticula associated with the transverse colon.Small amounts of fluidare present within the moderately gas-distended stomach.The patient had undergone prior lumbar spinal fixation surgery including the spinous process fixation at multlple levels within the lumbar spine.Impression: 1.Locules of free air in the anterior abdomen at the level of the mesogastrium likely near the access site of the patient's recently performed laparoscopic cholecystectomy.2.No definite evidence to suggest bowel perforation.3.No evidence for bile leak nor evidence for pathologic dilatation of the ivc.History: chest pain.Findings: there are no infiltrates or effusions.Heart size was normal.Osseous and soft tissue structures are unremarkable.Impression: no acute pathology.(b)(6) 2013 patient presented for mri cervical spine, indication: neck pain; previous cervical fusion in 2010.Findings: metallic susce posibility artifact at c5-6 compatible with prior acof procedure.No abnormal bone marrow signal to suggest fracture, infection, or neoplasm.There was mild straightening of the normal cervical lordosis, unchanged from the prior exam.The cervical cord was normal in caliber and signal intensity.The visualized posterior fossa contents are unremarkable.C2-c3: no spinal canal or neural foraminal stenosis.C3-c4: no spinal canal or neural foraminal stenosis.C4-c5: no spinal canal or neural foraminal stenosis.C5-c6: surgical level.Uncovertebral spurring and facet arthrosis create mild right neural foraminal stenosis, slightly progressed from the prior exam.No spinal canal or left neural foraminal stenosis, c5-c7: no spinal canal or neural foraminal stenosis.C7-t1: no spinal canal or neural foraminal stenosis.Impression: 1.Priors c5-c6 acdf, 2.Mild c5-c6 right neural foraminal stenosis, progressed from the 2011 comparison exam.(b)(6) 2013 mri c-spine scan of cervical: there was cervical straightening noted.She had a previous anterior cervical diskectomy and fusion at c5-6 but otherwise her study was really fairly benign.There was no obvious evidence of significant focal nerve compression or herniation.Certainly plain films would be appropriate to evaluate the status of her fusion.Musculoskeletal: not present- arthritis.Neurological: not present- numbness, weakness, stroke and headaches.Psychiatric: not present- depression.(b)(6) 2013 cervical spine w-3 vws.Indication: anterior cervical spine fusion and radiculopathy.Findings: two views of the cervical spine were submitted and compared to prior dated (b)(6) 2010.There was evidence for prior anterior cervical spine fusion endeavor involving c5-6.There was no evidence for hardware failure or loosening.There was some mild straightening of the normal cervical spine lordosis.The c7-t1 vertebral body was not well demonstrated on the lateral view.Impression: stable anterior cervical spine fusion at c5-6 without evidence for hardware failure or loosening.(b)(6) 2013 mri cervical spine: indication: neck and left shoulder pain radiating to the hand with numbness.Findings: what may be retention cyst was seen dependently within the sphenoid sinus.Remaining para vertebral soft tissue looks intact.Anterior cervical fusion with interbody plug and minor metal susceptibility artifact.At c5-6.Appearance was unchanged.Vertebral alignment was normal.Small lipoma or hemangiomas within the c7 and t5 bodies.No cerebellar tonsillar ectopia.C2-3, c3-4, and c4-5: unremarkable.C5-6: right uncinate spurring mildly encroaching the right lateral recess/neural foramen was unchanged.No central stenosis.Left neural foramen was patent.C6-7: disc bulging, more prominent towards the left, minimally encroaches the lateral recess with small uncinated spurring.This was more prominent since (b)(6) 2013.No stenosis.C7-t1: unremarkable.The thyroid was enlarged and heterogeneous in signal pattern with nodular component this was worse on the left.Suspect multinodular goiter.Ultrasound may be helpful.Impression: 1.Acf c5-6, unchanged.2.Mild uncinate spurring at c5-6 on the right with minimal foraminal/lateral recess encroachment, unchanged.3.Development of bulge c6-7 disc.4.Nodular, enlarged thyroid.(b)(6) 2013 ct cervical spine: indication; left arm numbness.Findings: anterior cervical fusion was again noted at.C5-6 with anterior plate and interbody screws.Fusion plug was in the disc space.There was normal vertebral body alignment.Facet alignment normal bilaterally.The atlantodens interval was normal the odontoid itself was intact.There was some mild bony foraminal stenosis on the right at c5-6 secondary to hypertrophy of the uncovertebral joint.There are no focal disc herniations.No central canal stenosis.Prevertebral soft tissues are not thickened.Impression: 1.Previous anterior fusion c5-6 with normal alignment.2.Mild bony foraminal stenosis on the right at c5-6.(b)(6) 2013 neurologic: cranial nerve exam was unrevealing.Upper and lower extremity motor strength was full throughout.Light touch sensation was diminished in the c5 distribution on the left side.Deep tendon reflexes are 1 + and symmetric at the biceps, brachioradialis and triceps.Knee jerks were 2+ and symmetric.Negative spurring test bilaterally.Negative hoffmann sign.She had positive tinel sign at the left elbow.Musculoskeletal exam reveals - normal bulk and tone and normal gait and station.Imaging studies: her emg and nerve conduction study shows a radiculopathy at c6-7 on the left.The patient's mri showed a disk bulge at c6-7 on the left, which was worse on the (b)(6), 2013 study in comparison with the (b)(6) of 2013 study.Fees vocal cord examination revealed significant changes of reflux, vocal cord movement was symmetric.Impression: cervical radiculopathy.(b)(6) 2013 patient was admitted with diagnosis of cervical radiculopathy, procedures: removal of c5-c6 anterior cervical plate, anterior cervical diskectomy and fusion c6-c7 with instrumentation.1.Anterior cervical diskectomy with interbody fusion, c6-c7.2.Anterior spinal instrumentation using the helix t -brand spinal plate nuvasive, c5 through c7.3.Use of interbody instrumentation with the 4 web titanium implant, c6-c7.4.Removal of spinal plate, c5-c6.5.Use of nonstructural local autograft for spinal fusion.6.Use of nonstructural allograft for spinal fusion (dbx demineralized bone matrix putty).Indications: (b)(6) 2013 patient was discharged from hospital.(b)(6) 2013 x-ray exam of neck spine.Imaging studies: the patient had undergone a cervical, thoracic, and lumbar myelogram.The cervical myelogram shows stenosis with cord compression at the c4-s level.There are disk herniations and/or neural foraminal narrowing seen at c5-6 and c6-7.(b)(6) 2013 cervical spine: findings: straightening of c-spine.Repeat surgery since (b)(6) 2013.Anterior fixation plate with screws c5 to c7.Metallic implant at the c6-7 disc space.Hardware projects in good position without evidence of loosening.Interbody plug at c5-6, likely incorporated.No fracture or subluxation was seen.No prevertebral soft tissue swelling.Impression: anterior fusion c5 to c7.Small posterior ridging at c4-5.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5044356
MDR Text Key24664932
Report Number1030489-2015-02141
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2010
Device Catalogue Number7510400
Device Lot NumberM110609AAE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/03/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/22/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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