MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CONCORDE LIFT EXPANDABLE CAGES CONVEX CAGE 9 X 21MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	US-1978-09-021C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.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.
Event or Problem Description
Sales rep reported to product director.Concorde lift failure.Complaint form sent to sales rep for details.Per complaint form: surgeon inserted cage at steep angle.Malleted the inserter and the back of the cage broke.
Additional Manufacturer Narrative
The concorde lift convex cage was returned for evaluation.Visual inspection identified that the cage was fractured through the central actuator screw.Optical imagining found evidence of a static overload.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot be positively identified however fracture analysis report suggests that the proximal wedge underwent angulation relative to the end plates resulting in bending of the central actuator screw which ultimately experienced a static overload failure.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 have been observed, 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 LIFT EXPANDABLE CAGES CONVEX CAGE 9 X 21MM
• 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: 6767526
• Report Number: 1526439-2017-10629
• Device Sequence Number: 13825568
• Product Code: MAX
• UDI-Device Identifier: 10705034531434
• UDI-Public: (01)10705034531434
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: US-1978-09-021C
• Device Catalogue Number: US197809021C
• Device Lot Number: 081616C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/12/2017
• Patient Sequence Number: 1
• Patient Age: 45 YR