MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONCORDE BUL LOR 9X8X27, 5 DG; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	187827408
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
When attempting to implant a concorde bullet interbody fusion cage, the cage broke into several pieces.The pieces were retrieved and will be sent back to the head office patient consequence? :no.Action taken for procedure:completed with another concorde bullet interbody fusion cage.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).One concorde bullet lordotic 9x8x27 5 degree cage was received by the customer quality unit for evaluation.Visual examination found that the cage had fractured into multiple pieces.A review of the device history record identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the concorde cage fracturing cannot be positively determined.However, it should be noted that polymer/carbon-fiber cages are designed to support physiologic loads.Higher than anticipated torque levels when applied to insertion tools, can cause splitting or fracture of cages.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, 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 BUL LOR 9X8X27, 5 DG
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7133002
• Report Number: 1526439-2017-50099
• Device Sequence Number: 19048514
• Product Code: MQP
• UDI-Device Identifier: 10705034140056
• UDI-Public: 10705034140056
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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: Health Professional
• Device Catalogue Number: 187827408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1