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 Ossification (1428); Neuropathy (1983); Pain (1994); Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  Injury  

Event Description

It was reported that the patient underwent a tlif spinal fusion procedure at l5-s1 using rhbmp-2/acs on (b)(6) 2011.Post-operatively, imaging studies ultimately showed that patient had developed uncontrolled bone growth and resulting nerve compression at the implant site.As a result, patient now suffers from injuries including chronic pain and radiculitis.

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

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) 2011: patient presented with following pre-op diagnoses: l5-s1 degenerative disk disease with annular tear; axial low back pain with left lower extremity radiculopathy.For which patient underwent following procedures: l5-s1 transforaminal lumbar interbody fusion; transpedicular approach; l5 laminectomy; posterior instrumented fusion l5-s1; intraoperative fluoroscopy; dual graft with amniotic tissue; bmp local bone and bone marrow aspirate from right iliac crest; platelet rich plasma.Components used: 25 mm x 10 mm interbody peek cage and posterior screws and rods were utilized.Per op notes, the disk space at l5-s1was identified.Local bone was mixed with bone marrow aspirate, that was taken with a jamshidi in the right iliac crest was placed along bmp.A quarter sponge of bmp was placed with the local bone and ¿bma¿ into the anterior aspect of the disk space.A 10 x 25 mm peek interbody cage was then placed with bmp local bone and ¿bma¿ inside of it.A quarter sponge of bmp along with ¿bma¿ and local bone were placed in the facet joint for fusion mass.Final ap and lateral views confirmed appropriate confirmed appropriate patient and interbody cage and the screws and amniotic tissue dural graft was placed over the dura at the laminectomy site of l5.Patient tolerated the procedure well with no complications reported.On (b)(6) 2013: patient underwent ct of lumbar spine without contrast due to lumbosacral radiculitis.Impression: postoperative changes from a transforaminal lumbar interbody fusion with solid osseous incorporation through the central aspect of the interbody graft.Posterior fixation construct at this level without hardware complication; mild spondylosis at l4-l5.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3917214
• MDR Text Key: 20783827
• Report Number: 1030489-2014-03091
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2013
• Device Catalogue Number: 7510400
• Device Lot Number: M111057AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2011
• 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