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

Catalog Number 7510800

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, patient presented with pre-op diagnosis of degenerative disk disease with annular tear , l4-5, with mechanical low back pain.The patient underwent anterior laparoscopic discectomy and fusion , l4-5; anterior interbody fusion with rhbmp-2 , allograft and autograft and prp matrix; implantation of cage fixation ; somatosensory evoked potentials.Per op-notes, ¿.Using the trapezoid cage , appropriate docking port was applied , drilling and then self tapping and a cave prepared.Next , the rhbmp-2 which had been soaked in the gelfoam like sponge for 15 mins was gently incorporated and placed into lt cage.¿ 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; ssep- somatosensory evoked potential.Per op-notes, ¿.Locking heads were then removed , and then the rod was securely withdrawn.The screws then had a torque wrench placed and the screws were withdrawn , identified no evidence of any loosening or motion or seromatous fluid.¿.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

A good faith effort will be made to obtain the applicable information relevant to the report.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: 5931560
• MDR Text Key: 54022788
• Report Number: 1030489-2016-02489
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M112001ABB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: 08/15/2016
• Supplement Dates FDA Received: 09/25/2017
• 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