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 Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.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: on (b)(6) 2008 the patient presented with pre- op diagnosis as follows unstable spondylolisthesis , l4-l5 and l5-s1.Degenerative lumber disk disease, l4-l5 and l5-s1.Vertical disk space collapse with instability.Acquired spinal stenosis, l4, l5 and s1 with radiculopathy secondary to unstable spondylolisthesis , l4-l5 and l5-s1.Degenerative lumbar disk disease, l4-l5 and l5-s1.Vertical disk space collapse with instability.The patient underwent the following surgeries: minimally invasive muscle sparing approach to the posterior spine, l4 to sacrum.Posterior spinal fusion, l4 to sacrum with segmental pedicle screw instrumentation.Posterior lumbar interbody fusion l4-l5 and l5-s1, using a far lateral extra cavity transforaminal approach from the left.Anterior interbody cage instrumentation l4-l5, and l5-s1, using a polymer cage, one for each level.Fusion with local autograft bone and bone morphogenic protein.As per op notes ¿ harvested local autograft bone was mixed with bone morphogenic protein sponge.This mixture was packed into the interspace against the anterior longitudinal ligament as well as to the right and left sides.Anterior interbody cage instrumentation was now performed by fashioning a polymer cage one for each level.These were packed with bone morphogenic protein sponge.They were impacted into an anatomic center-center position with an excellent press fit.Additional autograft bone was packed around the cage.¿ there were no complications recorded for the patient.On an unknown date post-op, patient alleged unspecified injuries due to use of rhbmp-2/acs.

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.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6208026
• MDR Text Key: 63358570
• Report Number: 1030489-2016-03587
• 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
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016
• Supplement Dates FDA Received: 09/27/2017
• 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: 58 YR