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 Disc Impingement (2655); 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) 2007: patient is presented with following pre-op diagnosis: lumbar spondylosis l4/5 possible l3/4, lumbar spinal stenosis l4/5, lumbar central disc herniation with stenosis l4/5.Patient underwent the following procedures: posterior spinal fusion l4/5, posterior spinal non segmental instrumentation with bone screws bilaterally into pedicles of l4 and l5.Posterior lumbar interbody fusion as separate and distinct surgical procedure from posterolateral fusion.Decompression centrally at the level of lateral recess, at the level of lateral recess, at the level of neuroforamen with complete discectomy l4/5 with visualization of both l4 and l5 nerve roots bilaterally for a distinct two nerve root decompression bilaterally.Utilizing of prosthetic machine peek allograft as interbody fusion l4/5.Utilization of local bone graft for fusion l4 to l5.Utilization of crushed cancellous allograft and bmp as fusion augmentation l4/5.As per op-notes: an incision was made in midline from l3 to l4 to l5.Dissection was carried out further laterally to level of l3/4 facet joints.At l4/5 there was marked facet hypertrophy, interspinous ligament between l4 and l5 spinous process were removed.Marked evidence of excitation of l5 neve roots bilaterally right side greater than left.Post-op diagnosis: lumbar spondylosis l4/5 possible l3/4, lumbar spinal stenosis l4/5, lumbar central disc herniation with stenosis l4/5.No evidence of facet hypertrophy and degenerative change at l3/4.On (b)(6) 2010: patient underwent mri lumbar spine with/without gadolinium.Impression: bulge at l3-4 with small right sided herniation.Central herniation at l5-s1 with epidural impingement.Central probable scar at l4-5 with epidural impingement.

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: 5899289
• MDR Text Key: 52831869
• Report Number: 1030489-2016-02407
• 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: 08/08/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 08/24/2016
• Supplement Dates Manufacturer Received: 08/08/2016
• Supplement Dates FDA Received: 09/25/2017
• 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): Other