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 Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.Multiple products 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) 2004, the patient presented with pre-op diagnosis of degenerative disc disease, angular tear l4-5.The patient underwent following procedures: posterior intralaminar partial interfacet fusion with rhbmp-2, allograft , autograft prp matrix at l4-5.M8 pedicle and rod , screw fixation , l4-5.Ssfp monitoring and direct pedicle screw stimulation.Per op-notes, ".Granules and the autograft to allograft was wrapped in the bmp sponge mixed with prp matrix.This was placed in the region expanding the l4-5 lamina interspace and sacral area." on (b)(6) 2005, the patient presented with residual low back discomfort over the instrumentation.Pre-op diagnosis of the patient was retained pedicle screw instrumentation with pseudoarthrosis.The patient underwent following procedures: removal of pedicle screw fixation ,l4-5; exploration of fusion ; scar revision 2 cm ; ssep- somatosensory evoked potential.Per op-notes, ".Locking heads were then removed , and then the rod was securely withdrawn.The screws then had a torque wrench placed and the screws were withdrawn , identified no evidence of any loosening or motion or seromatous fluid.".

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: 5931563
• MDR Text Key: 54022975
• Report Number: 1030489-2016-02490
• 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: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• 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: 08/15/2016
• 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
• Patient Age: 37 YR