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 Dysphagia/ Odynophagia (1815); Pain (1994); Weakness (2145)

Event Type  Injury  

Event Description

It was reported that the patient underwent posterolateral fusion from c3 through c6 using rhbmp-2/acs placed on the cervical spine.Post-op the patient developed increasing neck pain, difficulty swallowing, sensation of needing to clear his throat all the time, and weakness and loss of grip in both hands.

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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.

Manufacturer Narrative

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

Event Description

It was reported that the patient was presented with the following pre-op diagnosis: 1.Disk disruptions with spinal stenosis c3-c6 with previous anterior cervical decompression and fusion c3-c6 with instrumentation.2.Hardware failure anteriorly with clear motion at all levels c3-c6 requiring posterior cervical fusion and instrumentation.3.Prominent and failed left c6 screw with esophageal impingement.He underwent following procedures: 1.Posterolateral fusion, c3-c4.2.Posterolateral fusion.C4-c5.3.Posterolateral fusion, c5-c6.4.Segmental lateral mass screw fixation, c3-c6.5.Harvest of local autograft bone from partial facetectomies.6.Anterior exposure of cervical spine with removal of hardware (left c8 prominent screw).7.Monitoring of meps, sseps and emgs without any complications throughout.As per operative notes, "the facet joints and lateral masses were heavily decorticated down to bleeding bone.Partial facetectomies were done and local bone graft was harvested for fusion.This was mixed with crushed cancellous chips and rhbmp-2/acs and laid at c3-4 and c4-s, cs-c8 to achieve posterolateral fusions at all levels." no intra-op 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4485072
• MDR Text Key: 20127740
• Report Number: 1030489-2015-00234
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• 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
• Date Manufacturer Received: 04/02/2018
• 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