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	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While using a slap hammer to get the inserter out of the disc space, 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 properly in the disc space.This event is reportable.
Event or Problem Description
Surgeon was on the patient's right at l2-3 using 9mm ti coated peel banana cage (ref = 41532909-s // lot = n1a9x-n113y).Implant was impacted into disc space and articulated properly.The wheel of the inserter was turned to disengage the implant and a slap hammer was used to get inserter out of disc space.The proximal tantalum marker portion of the implant broke from the rest of the implant during this.The broken piece was retrieved and removed from the field.There was no harm to the patient and no delay to surgery.
Additional Manufacturer Narrative
While using a slap hammer to get the inserter out of the disc space, 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 properly in the disc space.This event is reportable.On (b)(6) 2024, it would appear that angulation is exerted when the patient's anatomy is complicated as well as when using the product with a minimally invasive technique.This brings us to the limits of the tlif tivac system.This procedure is, however, not described in the surgical technique.
Event or Problem Description
Surgeon was on the patient's right at l2-3 using 9mm ti coated peel banana cage (ref = (b)(4)/lot = n1a9x-n113y).Implant was impacted into disc space and articulated properly.The wheel of the inserter was turned to disengage the implant and a slap hammer was used to get inserter out of disc space.The proximal tantalum marker portion of the implant broke from the rest of the implant during this.The broken piece was retrieved and removed from the field.There was no harm to the patient and no delay to surgery.

• 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: 18480347
• Report Number: 3009962553-2023-00006
• Device Sequence Number: 6885975
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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?: No
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2022
• 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 Sex: Unknown