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

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

Patient Problems Ossification (1428); Nerve Damage (1979); Pain (1994); Paralysis (1997); Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent lumbar spinal fusion surgery at l3-l4 using rhbmp-2/acs with a posterior approach.Reportedly, sometime post-op, the patient developed osteophyte formation in his lumbar spine and severe bony narrowing of the central canal and foraminal stenosis.The patient experienced severe back pain, chronic leg pain, nerve damage, male sterility and paralysis.

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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.

Event Description

It was reported that on (b)(6) 2009, patient presented with following pre-op diagnoses: l3-4 instability, back pain, bilateral leg pain with extension of his back, lumbar instability, incompetent facet joints l3-4.For which, patient underwent following procedures: posterior lumbar interbody fusion l3-4, posterolateral fusion l3-4, using locally harvested autograft, bone morphogenic protein, pedicle screw instrumentation and biochemical cage, surgical microscope.Per op notes, trial spacer 10mm in height was placed in the disc space at l3-4.A 10 mm cage in longer length was then packed with a bone morphogenic protein sponge and then tapped into place.The cage was shown to be in good position by fluoroscopy.Surgeon also took an extra bone morphogenic sponge and pushed it medially within the interspace.Bone morphogenic protein sponges wrapped with autograft were then placed over bleeding bone on the left between l3-4 and on the right between l3-4.Patient tolerated the procedure well without any intraoperative complications.

• 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: 4271313
• MDR Text Key: 5225311
• Report Number: 1030489-2014-04526
• 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
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 55 YR