MAUDE Adverse Event Report: DEPUY SYNTHES SPINE BENGAL STACK LRG 10MM 0DEG MID; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	177300310
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device discarded.
Event or Problem Description
Procedure: cervical corpectomy.The patient was previously operated on (b)(6) 2017 for a 3/4 cervical fusion, 4/5 cervical disc arthroplasty and c5-7 cervical fusion.On the day the c5-7 fusion resulted in a corpectomy of c6 and a bengal stackable cage and skyline plate was implanted.The patient has presented with cage subsidence at c5-7.The surgeon has indicated that this was not a result of implant failure but due to the patient poor quality bone.Subsequently the c5-7 skyline plate and cage has been removed, a corpectomy of c7 has been performed and a longer stackable cage and plate has been implanted.Unfortunately the nurse had disposed of the implants so they are not able to be returned, however as stated earlier the surgeon has said that the subsidence was not due to any implant failure but due to poor bone quality.

• Brand Name: BENGAL STACK LRG 10MM 0DEG MID
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6674106
• Report Number: 1526439-2017-10526
• Device Sequence Number: 2059533
• Product Code: MQP
• UDI-Device Identifier: 10705034060521
• UDI-Public: (01)10705034060521
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 177300310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 53 YR