MAUDE Adverse Event Report: DEPUY SYNTHES SPINE BENGAL STACK LRG 9MM 0DEG TOP; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 177300209

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 06/04/2017

Event Type  Injury  

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 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 skykine 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 9MM 0DEG TOP
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6674042
• MDR Text Key: 78608898
• Report Number: 1526439-2017-10525
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10705034060491
• UDI-Public: (01)10705034060491
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K073649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Catalogue Number: 177300209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 53 YR