MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CONCORDE BULLET SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	187823408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not yet returned for evaluation.
Event or Problem Description
Implant became disconnected from implant holder and shattered during insertion into patient.This lay in situ and was removed before the procedure continued.Another cage was then successfully inserted into the patient.
Additional Manufacturer Narrative
Visual examination of the returned device found the cage was fractured into three pieces.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the cage fracturing intraoperatively cannot be determined from the sample and the information provided.A potential root cause may be unanticipated force inadvertently placed on the cage during impaction.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONCORDE BULLET SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6802077
• Report Number: 1526439-2017-10675
• Device Sequence Number: 10910338
• Product Code: MQP
• UDI-Device Identifier: 10705034139494
• UDI-Public: (01)10705034139494
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 187823408
• Device Catalogue Number: 187823408
• Device Lot Number: AHMCG5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/03/2017
• Patient Sequence Number: 1