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

Model Number (01)03700780627127(17)260701(10)M667X-M613Y

Device Problem Positioning Problem (3009)

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

Event Date 06/24/2022

Event Type  malfunction  

Event 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.

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.

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 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
• 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: 15138677
• MDR Text Key: 304631290
• Report Number: 3009962553-2022-00002
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 03700780627127
• UDI-Public: (01)03700780627127(17)260701(10)M667X-M613Y
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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