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

Catalog Number 41532909-S

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 333000843
• Report Number: 3009962553-2023-00006
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 41532909-S
• Device Lot Number: N1A9X-N113Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1