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 Nerve Proximity Nos (Not Otherwise Specified) (2647); No Code Available (3191)

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.(b)(4).

Event Description

It was reported that on: (b)(6) 2005: the patient presented with diskogenic back pain secondary to degenerative disk disease, l4-5 and underwent trans-foraminal lumbar inter-body fusion, l4-5, with mass instrumentation and pedicle screw fixation.As per-op notes, " the inter-space l4-5 was sized for the appropriate-size interbody device.The interbody device was then filled with bone morphogenic protein and tapped into place using fluoroscopic guidance.Pedicle screws were placed at l4-5 on the left side.The rod was placed through the screw heads.Pedicle screws were then placed in the pedicles of l4 and l5 on the left side.The wound was irrigated." no patient complications were reported.On (b)(6) 2006: the patient presented with lumbar spondylosis with exuberant fusion mass, l4-5, on the left causing nerve root compression.The patient underwent exploration of l4-5 foramen on the left with neurolysis of the l4 root and resection of exuberant bony overgrowth.No patient complications were reported.

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: 5688049
• MDR Text Key: 46162414
• Report Number: 1030489-2016-01596
• 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: 05/09/2016

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: 05/09/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: 05/09/2016
• Supplement Dates FDA Received: 09/22/2017
• 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