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

Model Number	(01)03700780627127(17)260701(10)M667X-M613Y
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While inserting a screw through the plate, one of the plate's locking sleeves remained slightly proud of the plate, preventing the screw from sitting flush in the plate.The screw was left in place.
Additional Manufacturer Narrative
While inserting a screw through the plate, one of the plate's locking sleeves remained slightly proud of the plate, preventing the screw from sitting flush in the plate.3 screws were used normally without problem.The fourth screw could not be implanted correctly into the plate preventing the screw from sitting flush in the plate.Even if this screw was left in place in a safe place, the closing mechanism did not work properly.Accordingly, this event is reportable as a malfunction.
Additional Manufacturer Narrative
While inserting a screw through the plate, one of the plate's locking sleeves remained slightly proud of the plate, preventing the screw from sitting flush in the plate.3 screws were used normally without problem.The fourth screw could not be implanted correctly into the plate preventing the screw from sitting flush in the plate.Even if this screw was left in place in a safe place, the closing mechanism did not work properly.Accordingly, this event is reportable as a malfunction.On 10/28/2022: response from manufacturer clariance sas: "as you know the r&d department asked for the x-rays of the patient to be able to analyze the incident.Knowing that we didn't get the x-rays, that you tried to get but no answer, we are sorry to say that we can't perform the analysis of this case.".
Event or Problem Description
While inserting a screw through the plate, one of the plate's locking sleeves remained slightly proud of the plate, preventing the screw from sitting flush in the plate.The screw was left in place.

• Brand Name: IDYS-ALIF
• Common Device Name: 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: 15138677
• Report Number: 3009962553-2022-00002
• Device Sequence Number: 5736470
• Product Code: OVD
• UDI-Device Identifier: 03700780627127
• UDI-Public: (01)03700780627127(17)260701(10)M667X-M613Y
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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 Expiration Date: 07/01/2026
• Device Model Number: (01)03700780627127(17)260701(10)M667X-M613Y
• Device Catalogue Number: 24430014-S
• Device Lot Number: M667X-M613Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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