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

Event Description

It was reported that on: (b)(6) 2008: the patient presented with following pre-op diagnosis: herniated nucleus pulposus l6-s1, spinal stenosis l6-s1, foraminal stenosis l5-s1, extruded herniation l6-s1, galt disturbance of lumbar spine, scoliosis in lumbar spine, spinal lumbar radiculopathy at left s1, spinal curve.The patient underwent the following procedures: left-sided transforaminal posterior inter-body fusion at l5-s1, cage instrumentation at l5-s1, pedicle instrumentation bilaterally at l5 and s1, transverse process posterior lumbar fusion at l6-s1, intra-operative biplane neuoroscopy of lumbar spine.As per the operative notes,¿ decortication of the endplates and irrigation copiously with normal saline was accomplished.Then bone morphogenic protein(bmp) and cancellous autologous bone were placed in the anterior aspect of the disc space at· l5-s1 followed by a 14 x 32 millimeter peek implant filled with cancellous autologous bone and bone morphogenic protein(bmp) was placed into the intra-discal space.¿ no intra-operative complications were reported.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7661844
• MDR Text Key: 113156127
• Report Number: 1030489-2018-00949
• 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: 07/04/2018

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: 06/11/2018
• Initial Date FDA Received: 07/04/2018
• 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