MAUDE Adverse Event Report: CLARIANCE SAS IDYS-TLIF TIVAC; IDYS TLIF TIVAC CAGE L29MM H09MM,

Catalog Number	41532909-S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon was on the patient's right at l4-5 using a 9mm ti coated peek banana cage with the 25-degree angled inserter.While impacting into the disc space, before articulating the inserter, the proximal tantalum marker portion of the cage broke from the rest of the cage.He was able to retrieve the broken portion and remove it from the disc space.He then used a tamp/pusher to position the rest of the cage accordingly.There was not a significant delay to the case, or any harm done to the patient because of the incident.All the broken pieces of the implant were removed from the patient and discarded by the surgical staff and can't be sent back for analysis.
Additional Manufacturer Narrative
While impacting the tlif cage into the disc space, before articulating the inserter, the proximal tantalum marker portion of the cage broke from the rest of the cage.The surgeon was able to retrieve the broken portion and remove it from the disc space.Then, the surgeon was able to position the rest of the cage accordingly.This event is reportable as a malfunction.
Additional Manufacturer Narrative
While impacting the tlif cage into the disc space, before articulating the inserter, the proximal tantalum marker portion of the cage broke from the rest of the cage.The surgeon was able to retrieve the broken portion and remove it from the disc space.Then, the surgeon was able to position the rest of the cage accordingly.This event is reportable as a malfunction.On 11/28/2023, this medwatch 3500a filing now includes the analysis report from the manufacturer.
Event or Problem Description
The surgeon was on the patient's right at l4-5 using a 9mm ti coated peek banana cage with the 25-degree angled inserter.While impacting into the disc space, before articulating the inserter, the proximal tantalum marker portion of the cage broke from the rest of the cage.He was able to retrieve the broken portion and remove it from the disc space.He then used a tamp/pusher to position the rest of the cage accordingly.There was not a significant delay to the case, or any harm done to the patient because of the incident.All the broken pieces of the implant were removed from the patient and discarded by the surgical staff and can't be sent back for analysis.

• Brand Name: IDYS-TLIF TIVAC
• Common Device Name: IDYS TLIF TIVAC CAGE L29MM H09MM,
• 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: magalie hennequin ; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 17746225
• Report Number: 3009962553-2023-00003
• Device Sequence Number: 5461243
• Product Code: OVD
• UDI-Device Identifier: 03700780628643
• UDI-Public: (01)03700780628643(17)270501(10)N1A9X-N113Y
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K183259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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 Catalogue Number: 41532909-S
• Device Lot Number: N1A9X-N113Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown