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

(b)(6).(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.

Event Description

It was reported that on (b)(6) 2005 the patient underwent the following procedures: 1.Posterior l4-5 and l5-s1 bilateral fusion, 2.Posterior l4-5 and l5-s1 segmental instrumentation, 3.L5-s1 left-sided hemilamectomy and mesial facetectomy and foraminotomy to treat the following pre-op diagnosis: l4-5 and l5-s1 annular tears, l4-5 and l5-s1 instability.Op notes: the pedicles at l4-5 and l5-s1 were "debried" bilaterally.The c-arm was pulled into positon.The pedicles at l4-5 and s1 were identified and then instrumented using 6.2 outer diameter screws.They were 45 mm long at all levels.Once the screws were inserted, more bone graft that had been obtained anteriorly was then packed into the lateral "qutters" and packed into the facet.This was augmented with rhbmp-2/acs.The rods were then contoured, then applied in the screws.These were polyaxial screws.Locking nuts were applied, then all of the locking nuts were approximately torqued locked the rod was used to perform a left sided l5-s1 foraminotomy, mesial facetectomy and nerve root exploration.The patient tolerated the procedure the procedure well and at the end of procedure was taken to the recovery room and judged to be stable and neurologically intact.

• 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: 5332474
• MDR Text Key: 34594029
• Report Number: 1030489-2015-03598
• 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
• Report Date: 11/30/2015

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: 11/30/2015
• Initial Date FDA Received: 12/29/2015
• 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