MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH COUGAR LS 18X10X60 LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	189160510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
It was reported that a cougar ls cage broke intra-operatively while being inserted.The broken pieces were removed easily without additional intervention.There was a surgical delay of 15 minutes due to retrieval of the broken cage.The procedure was successfully completed.Patient outcome was stable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Device evaluated by mfr: corrected.Evaluation codes: additional.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection of the returned device found the device was received in two (2) pieces.The break is oblique and located at the center of the device.The superior section appears to have plastically deformed prior to breaking.An additional hole (post manufacturing) exists in the middle section of the implant.The hole is indicative of intraoperative intervention of attempting to retrieve the distal broken half from the disc space.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 assignable root cause for the device breaking intraoperatively could not be determined based on the provided information.The most likely cause is impaction forces during attempted insertion while meeting anatomical resistance.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: COUGAR LS 18X10X60 LORDOTIC
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8407930
• Report Number: 1526439-2019-51432
• Device Sequence Number: 2326819
• Product Code: MAX
• UDI-Device Identifier: 10705034166186
• UDI-Public: (01)10705034166186
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K082128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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: 189160510
• Device Catalogue Number: 189160510
• Device Lot Number: 511783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1