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

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Edema (1820); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Urinary Tract Infection (2120); Weakness (2145); Tingling (2171); Stenosis (2263); Depression (2361); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Event Description

It was reported that the patient underwent a spinal fusion surgery on the lumbar region of her spine from l4-l5 using rhbmp-2/acs.The patient's post-op period included increasing radicular symptoms in her right leg and severe mechanical lower back pain.On (b)(6) 2011 the patient underwent a revision surgery.Reportedly, the patient continues to experience severe back pain.

Manufacturer Narrative

(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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2011: patient underwent us-gallbladder due to ruq pain, post prandial.Opinion: normal gallbladder ultrasound.Pancreas and abdominal aorta are obscured by bowel gas.(b)(6) 2010 patient presented to emergency room for nausea, htn,.

Manufacturer Narrative

Concomitant products: cage, plate, screw, rod (implant (b)(6) 2009; explant (b)(6) 2011).(b)(4).

Event Description

It was reported that the patient presented with the following pre-op diagnoses: spinal stenosis, spondylosis and degenerative spondylolisthesis.She underwent the following operations: laminectomy, fasciectomy, foraminotomy l4.Bilateral arthrodesis l4-5.Pedicle screw instrumentation l4-5.Laminectomy partial medial fasciectomy, foraminotomy at l5.Morselized autograft.Morselized allograft.Anterior lumbar discectomy radical.Anterior lumbar arthrodesis.Placement of anterior prosthetic device.Morsellized allograft surgery.Per the op notes, the appropriate size peek spacer was packed with morselized allograft and rhbmp-2/acs and impacted into position.Portions of the allograft was then placed over this graft and a 23 mm plate was applied with 1 screw 30 mm in length in l4, two screws 25 mm in length in l5.Satisfactory appearance of the instrumentations arthrodesis was obtained using biplanar fluoroscopic imaging.No patient complications were noted.(b)(6) 2009: the patient was discharged after combined anterior and posterior decompression fusion and instrumentation.There were no complications.(b)(6) 2009: the patient underwent routine non-contrast ct scan of the head.Conclusion: negative non-contrast ct scan of the head.Prior left frontal parietal craniotomy is noted.(b)(6) 2011: the patient underwent x rays of the chest for lumbar spondylosis.Impression: stable chest with chronic elevation of the right hemidiaphragm.(b)(6) 2011: the patient consulted for medical evaluation and management.She complained of low back pain and right extremity pain.Assessment: back pain status post surgery, hypertension, obesity.The patient also underwent intraoperative neurophysiologic monitoring.Conclusion: intraoperative neurophysiologic monitoring demonstrated intact sensory and motor pathways of the lower extremities.Electrical stimulation of the pedicle screws was suggestive of the intra osseous pedicle screw placement.The patient presented with the following pre-op diagnoses: lumbar spondylosis, lumbar radiculopathy, and degenerative spondylolisthesis at l5-s1.She underwent the following operations: partial hemi laminectomy, partial medial facetectomy and foraminotomy for decompression of the neural elements, l5-s1 right.Bilateral lateral arthrodesis, l5-s1 right.Pedicle screw instrumentation using new pedicle screw replacement at s1 through l5.Exploration with subsequent removal and reinsertion of screws and instrumentation at l4-5.Transforaminal interbody fusion, l5-s1.Placement of prosthetic spinal implant.Morselized autograft.Fluoroscopic localization.Micro dissection.No patient complications were noted.(b)(6) 2011: the patient was discharged from the hospital.(b)(6) 2011: the patient presented with right knee pain, hands tingling and bilateral foot numbness; assessment: back pain with radiation: chronic, controlled; pain, foot: chronic, not controlled; pain, hand: chronic, not controlled; pain, knee: chronic, not controlled.(b)(6) 2011: the patient presented with left knee pain, left heel pain, headache and status post fusion.Assessments: pain, knee: acute, moderate; chronic pain syndrome : chronic, controlled; pain, foot: acute, moderate.(b)(6) 2012: the patient presented for follow up on back pain, foot and knee.Assessment: back pain with radiation: chronic, controlled; anxiety state: chronic, controlled; pain, foot: chronic, controlled; pain, knee: chronic, controlled.(b)(6) 2012: the patient presented with pain in bilateral knee.Assessment: back pain with radiation: chronic, controlled.Anxiety s tate: chronic, controlled; generalized pain: chronic, controlled; pain, knee: chronic, controlled.(b)(6) 2013: the patient presented with complaint of bilateral leg pain.Assessment: osteoarthritis, knee: chronic, not controlled; anxiety state: chronic, not controlled; back pain with radiation: chronic, not controlled; back pain, low (lumbago): chronic, not controlled.(b)(6) 2013: the patient presented with complaints of pain in back, shoulders and left knee.Assessment: back pain, low (lumbago): chronic, controlled; anxiety state: chronic, not controlled; back pain with radiation: chronic, controlled; osteoarthritis, knee: chronic, controlled.(b)(6) 2013: the patient presented with pain in back with radiation and right knee.Assessment: pain, knee: chronic, controlled; anxiety state: chronic, controlled; back pain, low (lumbago): chronic, controlled; muscle spasm: chronic, not controlled.(b)(6) 2013: the patient underwent mri of cervical spine without contrast for cervical radiculopathy.Impression: degenerative change of the cervical spine, most prominent at c6-c7 where there was prominent disc space narrowing and end plate degenerative change.There was also probable mild chronic height loss at the inferior endplate of c6 and superior endplate of c7.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6)-2011: the patient presented with low back pain with right sided radicular symptoms.The pain radiates from the low back into the gluteal area, down to the posterolateral aspect of the thigh, and into the anterolateral aspect of the leg on the right side.She has some numbness in her left foot, but her primary complaint involves the right leg.Impression: recurrent lumbar radicular complaints after a lumbar fusion approximately 2 years ago.(b)(6)-2011: the patient underwent x-rays of the lumbar spine due to back pain.Findings: anterior and posterior stabilization metal hardware is present at l4-5.There is grade i anterolisthesis of l5 on s1 that does not appear to change significantly during flexion or extension.No other alignment abnormalities are demonstrated.The patient also underwent lumbar, cervical, and thoracic myelograms due to low back pain with right leg pain, neck pain with bilateral hand numbness and mid back pain.Impression: bilateral extradural defects at l5-s1 with small bilateral extradural defects at l3-4; normal cervical myelogram; normal thoracic myelogram.The patient underwent ct of the cervical pain due to neck pain with bilateral hand numbness.Impression: normal cervical spine ct.The patient underwent ct of the thoracic spine due to mid back pain.Impression: anterior hypertrophic spurring at multiple levels; otherwise normal thoracic spine ct.The patient underwent ct of the lumbar spine due to low back pain with right leg pain.Impression: degenerative disease and previous surgery with narrowing of each lateral recess at l5-s1 and no definite hnp or central stenosis.(b)(6)-2011: the patient presented for follow-up after radiology examinations.Impression: recurrent radicular symptomatology secondary to degenerative spondylolisthesis, which has progressed since her surgery almost three years ago.She has a motor deficit.(b)(6)-2011: the patient presented with the following indications for procedure: symptom of precordial chest discomfort, ischemic angina chest pain, concern of unstable angina; abnormal cardiac stress test; hypertension, hyperlipidemia, obesity; diabetes mellitus.The patient underwent a left-heart cathertization; coronary angiogram; lv gram.(b)(6)-2012: the patient underwent x-rays of the lumbar spine due to lumbar spondylosis.Impression: previous fusion surgery; grade i spondylolisthesis of l5 on s1 and there is a slight levorotoscoliotic curvature to the lumbar spine; there is mild multi-level disc space narrowing.The alignment of the spine is unchanged when compared to the prior study of (b)(6) 2011.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2011, : patient presented for office visit.On (b)(6) 2011: patient presented for office visit.Patient underwent ekg( electrocardiogram).On (b)(6) 2012, (b)(6) 2013 : patient presented for office visit.On (b)(6) 2013 patient presented due to lbp, stress.On (b)(6) 2014 the patient due to lumbago, cervicalgia.On (b)(6) 2014 patient presented due to muscle spasm and cervivcal ¿spondy¿.On (b)(6) 2016 patient presened due to pain in right leg.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2013: patient presented for office visit and complains of knee pain and right 3rd toe hurting.Assessment: hypertension, gerd, right foot pain.On (b)(6) 2013, (b)(6) 2014: patient presented for office visit.Assessment: hypertension, gerd on (b)(6) 2014: patient presented for office visit.On (b)(6) 2014: patient presented for office visit.Assessment: hypertension, gerd, anxiety, vertigo.On (b)(6) 2014: patient presented for office visit and complains of urinating a lot, dry mouth.Assessment: urinary tract infection.

Event Description

It was reported that on, (b)(6) 2010: patient presented for follow up and complains of mechanical low back pain and right sided radicular symptoms.Patient underwent bilateral lateral epicondyle injection due to lateral epicondylitis.There were no patient complications.On (b)(6) 2009: patient presented with chief complaint of painful paresthesia in the palm of the right hand and in the index finger of the right hand.Patient underwent upper extremity emg/ncv results.Conclusions: non - specific right hand neuritis not associated with any detectable abnormality by this edx.On (b)(6) 2009: patient presented for history and physical examination.Patient has history of severe mechanical low back pain.Patient complains of bilateral lower extremity pain and weakness.Further follow up showed marked dorsiflexor weakness on the right graded at l4-5.Review of her mri of lumbar spine shows foraminal stenosis bilaterally,eccentric to the right at l4-5 level.Impression: lumbar spondylosis with lateral recess stenosis bilaterally in a patient with progressive motor deficit.On (b)(6) 2009: patient presented for office visit.Patient has had a small amount of serosanuinous drainage from the wound and this is closed with 3-0 monofilament suture.Patient underwent x-ray of lumbar spine due to lumbar spondylosis.Impression: evidence of anterior,interbody and posterior fusion at l4-5 with anatomic alignment.On (b)(6) 2009: patient presented for follow up visit.On (b)(6) 2009:patient presented with pain in her left knee and tenderness and pain in si joint.The patient underwent routine non-contrast ct scan of the head.Conclusion: negative non-contrast ct scan of the head.Prior left frontal parietal craniotomy is noted.Patient underwent x-ray of lumbar spine due to low back pain.Impression: stable appearing post fusion changes at the l4-5 disc level with no complicating process identified.On (b)(6) 2009: patient presented with chief complaint of left elbow pain with some radiation down the forearm to the hand.She has pinpoint tenderness over the lateral epicondyle.And patient underwent lateral epicondyle injection without any complication.Patient still having some over the right si joint and the sacral sulcus.On (b)(6) 2009:patient underwent x-ray of lumbar spine due to lumbar spondylosis.Impression: new grade 1 anterolisthesis l5 to s1.Stable appearance to anterior,interbody and posterior fusion l4-l5.Patient presented with chief complaint of weakness in the hands,pain in the right wrist and paresthesis in the hands as well as severe pain in the si joint bilaterally.Patient underwent upper extremity emg/ncv results.Conclusion: there is clinically evidence of possible bilateral sensory median compressive neuropathy across the carpal tunnel that may be worse in the left than the right.However this is not substantiated by this study.(b)(6) 2011, : patient presented for office visit.On (b)(6) 2011: patient presented for office visit.Patient underwent ekg(electrocardiogram).On (b)(6) 2012, (b)(6) 2013 : patient presented for office visit.

• 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 Key: 3606830
• MDR Text Key: 15330237
• Report Number: 1030489-2014-00408
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2011
• Device Catalogue Number: 7510400
• Device Lot Number: M110801AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 134