MAUDE Adverse Event Report: CLARIANCE SAS CLARIANCE IDYS-LLIF 3DTI; LUMBAR INTERVERTEBRAL BODY FUSION DEVICE WITH BONE GRAFT

Model Number	51430013-S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon inserted the cage + plate assembly.He was unhappy with the cage position.He decided to remove the cage + plate assembly.While extracting the cage + plate assembly and using slap-hammer, the plate disconnected from cage.As a result, cage remained in the disc space.An instrument available during surgery was used to remove cage out of the disc space.The surgeon re-inserted the cage + plate assembly and the plate disconnected again.As a consequence, the product was used without plate.No harm was caused to the patient.As originally planned, a posterior fixation was used to back-up the cage.Delay in surgery was about 15 minutes.
Additional Manufacturer Narrative
Due to the plate connection problem, idys-llif cage was left implanted with no plate or screws by the surgeon.Originally planned in the pre-op strategy, pedicle screws were inserted posteriorly to stabilize the cage and the segment.However, idys-llif is intended to be used as a construct comprised of one cage, one plate and two screws.
Event or Problem Description
Surgeon inserted the cage + plate assembly.He was unhappy with the cage position.He decided to remove the cage + plate assembly.While extracting the cage + plate assembly and using slap-hammer, the plate disconnected from cage.As a result, cage remained in the disc space.An instrument available during surgery was used to remove cage out of the disc space.The surgeon re-inserted the cage + plate assembly and the plate disconnected again.As a consequence, the product was used without plate.No harm was caused to the patient.As originally planned, a posterior fixation was used to back-up the cage.Delay in surgery was about 15 minutes.
Additional Manufacturer Narrative
Due to the plate connection problem, idys-llif cage was left implanted with no plate or screws by the surgeon.Originally planned in the pre-op strategy, pedicle screws were inserted posteriorly to stabilize the cage and the segment.However, idys-llif is intended to be used as a construct comprised of one cage, one plate and two screws.

• Brand Name: CLARIANCE IDYS-LLIF 3DTI
• Common Device Name: LUMBAR INTERVERTEBRAL BODY FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 11994829
• Report Number: 3009962553-2021-00002
• Device Sequence Number: 3819805
• Product Code: MAX
• UDI-Device Identifier: 03700780634521
• UDI-Public: (01)03700780634521(17)251101(10)K678X-K633Y
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K202032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace,Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 11/01/2025
• Device Model Number: 51430013-S
• Device Catalogue Number: 51430013-S
• Device Lot Number: K678X-K633Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1