MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONCORDE BUL PAR 9X11X27; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187827111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted 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.
Event or Problem Description
The device has broken during surgery in the patient.Device removed and replaced with another cage.
Additional Manufacturer Narrative
The concorde cage was not returned for evaluation.A device history record review could not be conducted as the lot number is unknown.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.Without the return of the cage, we are unable to confirm the reported issue or identify the root cause.As no systemic trends have been observed, this complaint file will be closed with no further action required.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 not returned.

• Brand Name: CONCORDE BUL PAR 9X11X27
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6676351
• Report Number: 1526439-2017-10530
• Device Sequence Number: 16636926
• Product Code: MAX
• UDI-Device Identifier: 10705034139920
• UDI-Public: (01)10705034139920
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081917
• 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): 06/07/2017

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: 187827111
• Device Catalogue Number: 187827111
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1