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 Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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.

Event Description

It was reported that on (b)(6) 2007 the patient underwent 1) laminectomy l2-3, l3-4 with laminectomy, foraminotomy, inferior facetectomy l4-5 and l5-s1.2) transforaminal discectomy l4-5 and l5-s1.Interbody cage insertion (cage with bone morphogenic protein) l4-5 and l5-s1.4) posterior lateral interbody fusion with local bone graft l4-5, l5-s1.5) posterior lateral spinal fusion with legacy segmental instrumentation l1 to s1.6) implantation of ebi bone growth stimulator.Preoperative diagnosis: 1) lumbar disc herniation with spinal stenosis, l4-5, l5-s1, lesser amounts at l3-4.2) lumbar scoliosis.Per-op notes: decompression was started distally and moving proximally the laminectomy, foraminotomy and inferior facetectomy at l5-s1, followed by l4-5.There was definitely some ligamentum flavum hypertrophy.A transforaminal discectomy was carried out at l4-5 and l5-s1 with curets, rongeurs, and disc shavers.Each pedicle was tapped and probed and no disruptions were found.Decortication of the transverse processes and the outer portion of the facet joints, as well as sacral ala, were completed with a but bilaterally.The legacy transpedicular screws were then placed at each level and triggered emg stimulation of all screws was normal.At the l4-5 and l5-s1 cage filler with bone morphogenic protein was inserted into the interbody space.The posterior lateral interbody fusion was completed using local bone graft at both l4-5 and l5-s1.This was follo wed by placement of bone grafting material in the posterior lateral gutters, including local bone graft, bmp and bone graft.After the general posterior lateral fusion from l1 to sacrum, intraoperative x-ray showed excellent position of all implants.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5333093
• MDR Text Key: 34644565
• Report Number: 1030489-2015-03600
• 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
• Report Date: 11/30/2015

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: 10/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110606AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2007
• 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