MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CONCORDE BUL PAR 9X10X23; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187823110
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
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
On (b)(6) 2018, the surgery for lcs was performed by using the concorde system.The fixed area was l4 ¿ l5.Due to a failure of threads of the connection part to the holder, the reported device could not be held.Other implant device was used to complete the procedure.The surgery was completed with no delay, and there was no adverse consequence to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned concorde bul par 9x10x23 revealed signs of operative usage.Threads on the threaded hole of the implant were slightly damaged, consistent with the damage due to unanticipated torque applied.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause of the concorde bullet thread damage and not being able to be inserted cannot be determined from the sample and information available.A potential root cause may be having it not fully engaged with the inserter.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 BUL PAR 9X10X23
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; CH
• MDR Report Key: 7324533
• Report Number: 1526439-2018-50214
• Device Sequence Number: 16173051
• Product Code: MAX
• UDI-Device Identifier: 10705034139357
• UDI-Public: (01)10705034139357
• Combination Product (Y/N): N
• PMA/510(K) Number: K041722
• 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): 02/16/2018

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 Model Number: 187823110
• Device Catalogue Number: 187823110
• Device Lot Number: 155671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1