MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Proximity Nos (Not Otherwise Specified) (2647)

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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on: (b)(6) 2010, patient underwent following surgery: c2, c3, c4, c5 and c6 decompressive laminectomy, facetectomies and foraminotomies with c2 to c6 posterior segmental instrumentation, c2 to c6 posterolateral arthrodesis.Stealth image guidance and intra-op fluoroscopy with unusual procedural services modifier on each cpt code; due to pre-op diagnosis of: cervical spondylotic myelopathy.As per op-notes: "a piece of gelfoam was placed over the dura and then rhbmp-2/acs sponges filled with autograft were placed laterally as well as packed in the drilled up facets.The patient was transferred to icu in satisfactory condition." on (b)(6) 2013, patient underwent following procedure: c6-7 decompressive laminectomy, facetectomy and foraminotomy; c6-7 posterior arthrodesis; c6-7 posterior non-segmental instrumentation; exploration of spinal fusion; removal of posterior segmental hardware; allograft; intra-op fluoroscopic interpretation; for pre-op diagnosis of: right c6-7 foraminal stenosis with radiculitis.No complications were reported.The patient alleges unspecified injury due to the use of rhbmp-2.

• 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
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5633369
• MDR Text Key: 44450273
• Report Number: 1030489-2016-01333
• 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: 04/18/2016

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
• Device Expiration Date: 11/01/2012
• Device Catalogue Number: 7510600
• Device Lot Number: M110812AAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: 04/18/2016
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2010
• 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: 48 YR