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 08/15/2023

Event Type  malfunction  

Event 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.

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.

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 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
• 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: 17746225
• MDR Text Key: 323704852
• Report Number: 3009962553-2023-00003
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 03700780628643
• UDI-Public: (01)03700780628643(17)270501(10)N1A9X-N113Y
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41532909-S
• Device Lot Number: N1A9X-N113Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1