MAUDE Adverse Event Report: CLARIANCE SAS IDYS-ALIF; IDYS-ALIF PLATE H14MM

Model Number (01)03700780627127(17)270201(10)I750C-IA08Y

Device Problem Material Separation (1562)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported to us that during idys-alif tivac surgery, upon impaction of the cage and plate into the disc space, two locking rings separated from the plate.The two rings were retrieved by the surgeon.As a consequence, 2 screws were used instead of 4 to secure the plate.Originally planned in the pre-op strategy, pedicle screws will be implanted.This event is reportable as a malfunction.

Event Description

The plate was attached to the alif cage and placed on the inserter.Upon impaction of the cage into the disc space both of the bottom locking rings on the plate became loose and disengaged from the plate.This happened during the placement of the cage and before the screws were introduced.According to the surgeon and the representative present during the case, there was nothing out of the ordinary that took place and no excessive force was used.The surgeon removed the loose rings with pick-ups and secured the cage to the l5 vertebral body using two screws without securing the plate to s1.The two disengaged rings were disposed of into the sharps container before the representative could secure them to be sent back for evaluation.No injury to the patient or significant delays were reported.

Manufacturer Narrative

It was reported to us that during idys-alif tivac surgery, upon impaction of the cage and plate into the disc space, two locking rings separated from the plate.The two rings were retrieved by the surgeon.As a consequence, 2 screws were used instead of 4 to secure the plate.Originally planned in the pre-op strategy, pedicle screws will be implanted.This event is reportable as a malfunction.

Event Description

The plate was attached to the alif cage and placed on the inserter.Upon impaction of the cage into the disc space both of the bottom locking rings on the plate became loose and disengaged from the plate.This happened during the placement of the cage and before the screws were introduced.According to the surgeon and the representative present during the case, there was nothing out of the ordinary that took place and no excessive force was used.The surgeon removed the loose rings with pick-ups and secured the cage to the l5 vertebral body using two screws without securing the plate to s1.The two disengaged rings were disposed of into the sharps container before the representative could secure them to be sent back for evaluation.No injury to the patient or significant delays were reported.

• Brand Name: IDYS-ALIF
• Type of Device: IDYS-ALIF PLATE H14MM
• 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: 16400618
• MDR Text Key: 310079796
• Report Number: 3009962553-2022-00003
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 0370078062651
• UDI-Public: (01)0370078062651(17)251001(10)K7D9X-K726Y
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2023
• Device Model Number: (01)03700780627127(17)270201(10)I750C-IA08Y
• Device Catalogue Number: 24430014-S
• Device Lot Number: I750C-IA08Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2021
• 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