MAUDE Adverse Event Report: CLARIANCE SAS IDYS-TLIF TIVAC; TLIF CAGE

Model Number	41532909-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgery was extended by 35 minutes as a result of the cage breakage.
Event or Problem Description
The tlif cage broke when being maneuvered into position after the cage was initially inserted through the anterior portion of the disc.It was reported that the cage sheered off in half as the surgeon was pulling back on the inserter.After several attempts, the 2 pieces were removed.A second cage was successfully inserted.No patient harm was reported and the surgery was able to be completed without further incident.

• Brand Name: IDYS-TLIF TIVAC
• Common Device Name: TLIF CAGE
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer (Section G): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer Contact: fadwa bahr ; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 9655858
• Report Number: 3009962553-2019-00009
• Device Sequence Number: 2787934
• Product Code: MAX
• UDI-Device Identifier: 03700780628643
• UDI-Public: 03700780628643
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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 Expiration Date: 11/29/2023
• Device Model Number: 41532909-S
• Device Catalogue Number: 41532909-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 01/31/2020
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female