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

Catalog Number 7510400

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

Patient Problems Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient code: (b)(4) (revision surgery).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.

Event Description

It was reported that on: (b)(6) 2014: the patient was pre-operatively diagnosed with status post transforaminal lumbar interbody fusion l4-l5 with failed hardware and pseudoarthrosis with axial back pain and secondary stenosis at l3-l4 and radicular pain and post-operatively diagnosed with status post transforaminal lumbar interbody fusion l4-l5 with failed hardware and pseudoarthrosis with axial back pain and secondary stenosis at l3-l4 and radicular pain with large synovial cyst l3-l4 left.For which, the patient underwent following procedures: total laminectomy l3, partially of l4 and l2 with medial facetectomy and foraminotomy to decompress the l4 nerve roots bilaterally with excision of large synovial cyst l3-l4 left.Removal of pedicle screws l4 and l5 bilaterally (l5 broken) posterolateral fusion s1,l5,l4,l3 bilaterally using right iliac autograft/marrow/vitoss/bmp.Pedicle screw fixation s1 to l3 with zimmer dto system.As per op notes:¿pedicle screws at l3 and s1 and replaced the l4 screws with a larger 6 mm screw part of the zimmer dto system.Two pledgets of the bmp was used.¿ on (b)(6) 2016: the patient was pre-operatively diagnosed with osteomyelitis of the lumbar spine, chronic indolent with lumbar instabil ity and secondary lumbar stenosis.Patient underwent following procedures: total laminectomy of l3, partially of residual l4 with medial facetectomy and foraminotomy to decompress the l3 and l2 nerve roots exploration from the left of the l2 to l3 osteomyelitic interspace with culture of interspace phlegmon removal of pedicle screw construct l3, l4 and s1; removal of imbedded fracture screws at s1 and l5 bilaterally.Placement of pedicle screw rod construct t12 to l1 (synthes expedium- cortical fix) with posterolateral fusion at all levels using dbm (synthes vivigen) and vitoss and harvested local bone.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6728385
• MDR Text Key: 80551865
• Report Number: 1030489-2017-01798
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• 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
• Report Date: 06/21/2017

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: 7510400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/20/2017
• 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
• Patient Age: 61 YR