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); Pain (1994); Tingling (2171); Stenosis (2263); Arachnoiditis, Spinal (2390); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Literature citation: ramsis f.Ghaly, alexei lissounov, tatiana tverdohleb, david kohanchi, kenneth d.Candido, nebojsa nick knezevic "spinal neuromodulation as a novel surgical option for failed back surgery syndrome following rhbmp exuberant bony growth in instrumented lumbar fusion: a case report and literature review." (b)(4).(revision surgery, persisting back pain, foot drop).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.

Event Description

In the literature titled " spinal neuromodulation as a novel surgical option for failed back surgery syndrome following rhbmp-2 exuberant bony growth in instrumented lumbar fusion: a case report and literature review " it was reported that on an unknown date, post-op, patient presented with persistent severe low back pain, right lower extremity pain, numbness, stenosis, arachnoiditis, tingling and partial right foot drop which did not improve with conservative treatment and four back surgeries.The third surgery proceeded with an instrumented spinal fusion, which was based on left l5 laminar fracture, right l5 spondylolytic defect around the area of previous foraminotomy, and current l5 laminectomy.An instrumented fusion was accomplished using rod system, allograft rhbmp-2 with a transforaminal lumbar interbody fusion approach (tlif).Despite the surgery, the patient had persistent pain at the right, more than left lower extremity, and lower back pain.After third surgery the patient underwent a revision surgery for removal of heterotropic bone growth and hardware.

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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6434959
• MDR Text Key: 70860432
• Report Number: 1030489-2017-00600
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

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?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: 03/01/2017
• Supplement Dates FDA Received: 10/02/2017
• 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): Required Intervention
• Patient Age: 58 YR