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 Inflammation (1932); Pain (1994)

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) 2008: patient presented with following pre-op diagnoses: lumbar stenosis.Lumbar disk herniation.For which, patient underwent following procedures: l4-l5 and l5-s1 decompressive laminectomy with medial facetectomy and foraminotomy for decompression of neural tissue under microscopic dissection.L4-l5 and l5-s1 diskectomy with interbody fusion with peek cages and bmp.L4-l5 and l5-s1 posterior lateral arthrodesis with autograft, allograft, bmp.Pedicle screw fixation segmental at l4, l5 and s1 with modular fixation system.Stereotactic navigation with the o-arm.Interpretation of fluoroscopy.Per op notes, surgeon applied peek cages filled with bmp at l5-s1, one on each side, and at l4-5, one on each side, using 10 mm cages at l5-s1 and 12mm cages at l4-5.At that point, decorticated the transverse process of l4, l5 and s1 and performed posterolateral arthrodesis using a combination, rolled around it bmp of a large kit and used that for posterolateral arthrodesis of l4-l5 and l5-s1.Patient tolerated the procedure well without any intraoperative complications.

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: 6207994
• MDR Text Key: 63359708
• Report Number: 1030489-2016-03560
• 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,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110703AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2008
• 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
• Patient Age: 47 YR