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

Catalog Number 7510200

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

Patient Problems Neuropathy (1983); Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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) 2007: the patient was pre-operatively diagnosed with spondylolytic spondylolisthesis, l5-s1, with foraminal spinal stenosis a nd degenerative lumbar disk disease, l4-l5 and underwent the following procedures: gill laminectomy, l5, with bilateral l5-s1 foraminotomies.Transforaminal interbody fusion, l4-l5 and l5-s1, with cage implementation using rhbmp-2 and local bone graft.Posterolateral fusion, l4-l5 and l5-s1.Pedicle screw fixation, same levels, using titanium instrumentation, including ssep and emg monitoring, local bone graft, allograft and rhbmp-2 augmentation.As per the op-notes: ¿disk debris was re-inspected for rh-bmp-2/acs was reconstituted.A peek cage was then obtained and filled with a bmp sponge.A single bmp sponge was first placed into the disk space across the midline.Laminectomy bone was morselized at this point.Bone graft was placed into the disk space and packed across the midline.With the nerve roots and dura carefully protected the cage was impacted in a crosswise fashion firmly seating the cage into the disk at l4-l5 creating good distraction of the interspace.The disk space was sized for an appropriate sized cage.At this point, a rhbmp-2/acs sponge was packed again across the midline along with cancellous graft being packed into the interspace.With the nerve roots and dura carefully protected, a cage was filled with a second rhbmp-2/acs sponge was impacted firmly into the disk space and countersunk appropriately.The remaining bone graft along with rhbmp-2/acs and allograft was then placed posterolateraly to augment bone graft volume and quantity.The laminectomy defect was inspected at this point to ensure no bone graft had migrated back into it.¿ post surgery, the patient was marked by progressively worsening pain in his low back, with radiculopathy into his left lower extremity.He underwent two revision sugeries due to severe pain and ongoing symptoms.Currently, the patient continues to experience lower back pain that radiates into the lower extremities.He is unable to enjoy his daily activities that he enjoyed pre-operatively, and has suffered serious and permanent injuries.

• 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: 6809449
• MDR Text Key: 83194044
• Report Number: 1030489-2017-01947
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• 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: 07/31/2017

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 Expiration Date: 06/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110701AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2007
• 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; Required Intervention
• Patient Age: 44 YR