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 Cyst(s) (1800); Urinary Retention (2119); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer.Therefore,cause of event cannot be determined.

Event Description

It was reported that on (b)(6) 2008: patient underwent mri lumbar spine without contrast.Impression: moderate circumferential bulging of disc material with bilateral neural exit foraminal stenosis at l4-l5 associated with an annular tear.(b)(6) 2008: patient underwent lumbar mri which showed a severely degenerated lumbosacral disc with early.There was also a midline annular tear visible.The surgeon believed patient was suffering from mechanical back pain from degenerative disc disease.(b)(6) 2008: patient had low back pain, diffusely radiating to the hips and buttock and at times diffusely radiating to legs in a non-radicular fashion, radiculopathy, muscle cramps, groin pain.Pre-op diagnosis: l5-s1 degenerative disc diseases with collapse and some foraminal entrapment.The patient underwent the following procedure anterior lumbar inter body fusion at l5-s1.Per op notes, the surgeon cleared out the disk space and placed the appropriate cages and bmp.The endplates were prepped.The hardware placement device was positioned, and the endplates were further decorticated.The peak spaces were screwed in place.The patien's own bone dust and some bone morphogenic protein were placed.An epidural type pain pump was positioned for local infusion to relieve wound pain.The patient developed the fever as well as productive cough.The chest x-ray was done at and showed evidence of atelectasis.The patient instructed on using incentive spirometry.The patient was discharged on (b)(6) 2008.The patient tolerated the procedure well and no complications were reported.(b)(6) 2008: patient underwent radiology test of chest pa and lateral because of postoperative fevers.Impression: linear atelectasis at the left lung base.The lungs otherwise are clear.(b)(6) 2008: patient underwent ct abdomen and pelvis with contrast because of difficulty in urinating status post-surgery.Impression: no acute abnormalities are clearly identified on this ct scan of the abdomen and pelvis status postop.(b)(6) 2008: patient underwent mri lumbar spine combined because of back pain.Impression: disk desiccation with circumferential disk bulge causing bilateral neural foraminal encroachment of l4-l5.(b)(6) 2008: patient underwent x-rays.Impression: mild degenerative changes lumbar spine.No abnormal motion with flexion or extension.Satisfactory appearing inter body fusion l5-s1.25 nov 2008: patient presented for office visit.(b)(6) 2009: patient examined for examination of complete abdomen due to a unable to have bowl movement.Impression: 1.Non obstructive bowel gas pattern.(b)(6) 2010: patient underwent mr lumbar spine with contrast due to lumbar pain and post lami syndrome impression: 1.New pathologically enhancing epidural process within the ventral aspect of the canal at the lower lumbar spine detailed above.Findings suspicious for epidural abscess.(b)(6) 2009: patient presented for examination of complete abdomen due to stool in blood.Impression: 1.No significant interval changes.(b)(6) 2009: patient underwent l-spine mri with and without contrast due to low back pain.Impression: 1.Moderate narrowing of the neural foramina bilaterally at l4-5.2.Status post fusion at l5-s1 in good alignment.(b)(6) 2009: patient underwent gallbladder ultrasound due to gallstones and abdominal pain.Impression: unremarkable gallbladder ultrasound.Patient also underwent examination of abdomen complete series with pa chest.Impression: unremarkable chest and bowel gas pattern.No evidence of pneumatosis or free air.(b)(6) 2010: patient underwent ct brain head without contrast due to headache, dizziness.Impression: 1.No evidence of an acute intracranial process.2.Please note mri is more sensitive for the evaluation of acute ischemia, if indicated 3.Suggestion of mildly low lying cerebellar tonsils with prominence of the cerebellar vermis likely related to the low-lying tonsils and low posterior fossa volumes.This could be further evaluated with dedicated mri evaluation on a non-emergent basis.(b)(6) 2010: patient underwent ct of the abdomen and pelvis because of pelvic or back pain.Impression: no definite cause of patient's pelvic pain identified.Patient also underwent cr abdomen comp decub erect because of back pain, bright red stool, abdomen pain.Impression: 1.No acute findings.Patient also underwent ct pelvis and abdomen without contrast due to flank pain.Impression: no acute findings.27 jul 2010: patient underwent examination of lumbar spine due to low back pain impression: no lumbar spine abnormality.(b)(6) 2011: patient underwent cr spine lumbar 2 or 3 vws because of back, legs and neck pain.Impression: 1.Mild degenerative change with no acute fracture or subluxation seen.2.Moderate amount of retained stool within the colon greatest on the right.Patient also underwent cr pelvis because of mva and leg pain.Impression: 1.No definite pelvic fracture seen.2.Note is made of transitional lower lumbar vertebral body articulating to superior sacrum with degenerative change noted.Patient also underwent cr spine cervical min because of mva and neck pain.Impression: 1.Moderate degenerative disc change with some straightening of cervical spine noted.If the patient remains symptomatic, consider follow up mri.2.Mild narrowing of left c3-c4 and c4-c5 neural foramen.The right neural foramina are not well evaluated on the oblique view.(b)(6) 2011: patient underwent examination of hip right due to groin pain.Impression: there is minimal hip arthritis, but there are some cystic changes along the lateral acetabular margins, which could imply some labral pathology.Please clinically correlate.Patient also underwent examination of hip left due to groin pain.Impression: there is minimal hip arthritis, but there are some cystic changes along the lateral acetabular margins, which could imply some labral pathology.Please clinically correlate.(b)(6) 2012: patient underwent pelvic echo and transvaginal us due to pelvic pain.Impression: 1.Status post hysterectomy and right oophorectomy 2.Left ovary is normal 3.No free fluid in the pelvis (b)(6) 2013: patient underwent mri lumbar due to low back pain that radiates down both legs.Impression: 1.Mild narrowing of the neural foramina bilaterally at l3-l4.2.Broad-based midline and para midline disc herniation at l4-ls more prominent on the right side impinging on the right ls nerve root.3.Moderate to severe narrowing of neural foramina bilaterally at l4-ls.4.Status post anterior fusion at ls-s1 in good alignment.14 mar 2013: patient underwent radiology exam of lumbar spine with bending due to lower back pain impression: 1.No significant change.2.Hardware and bony fusion, l5-s1.(b)(6) 2012, 17 apr 2013: patient underwent radiology exam of chest and lateral.Impression: normal chest examination.

• 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: 5024170
• MDR Text Key: 23803616
• Report Number: 1030489-2015-02043
• 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
• Reporter Occupation: Attorney
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110704AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2008
• 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): Other
• Patient Weight: 78