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 Nerve Damage (1979); 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.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.

Event Description

It was reported that on (b)(6) 2009, the patient was pre-operatively diagnosed with degenerative disc disease with intractable back pain and failed hardware posteriorly.Indications for procedure: the patient had had some disk problems in the past, he had been fused, which failed and the patient has now presented for a refusion of the l4-5 disk space.It was also noted that the motion-sparing device placed atop of the fusion construct failed with the cable connecting the pedicle screws had broken.He underwent 360 degree fusion l4-l5 with hardware removal and replacement of instrumentation posteriorly.As per the op-notes, ¿once an adequate discectomy had been performed and the end plates prepared for fusion, the trial implants were placed and felt to be filled best with a 16 mm peek cage, the cages were then opened on the back table and a large rhbmp-2/acs had already been opened and soaked on the back table.The cages were then packed with the rhbmp-2/acs and some hydroxyapatite/coral granules and the rhbmp-2 collagen sponges were then packed around the cages.The patient was then transferred to prone position on the osi jackson frame and utilizing the scar from previous incision the lumbar spine was opened dissecting the paraspine musculature and scar tissue off of the remaining posterior spinal elements exposing the broken hardware.The locking caps were then removed bilaterally as well as the cross-link.Once this was complete the broken portions of this motion preservation device were removed and handed off on the back table.The screws at l4 and l5 bilaterally were checked and felt to have good purchase still.Once this was completed 60 mm lordotic rods were then placed within the saddles of the pedicle screws from l4-s1.The facet joints were decorticated using a high speed bur and small amount of rhbmp-2/acs was packed within the decorticated portion of the facet joint.¿ post-operatively, the patient reported pain and nerve 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: 6826280
• MDR Text Key: 83839206
• Report Number: 1030489-2017-01968
• 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: 08/07/2017

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: 01/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110801AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2008
• 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