MAUDE Adverse Event Report: CLARIANCE SAS IDYS-ALIF; IDYS-ALIF CAGE 26X32 - H16MM - 14

Model Number 24520614-S

Device Problem Expiration Date Error (2528)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 an expired cage was implanted into a patient during surgery.

Manufacturer Narrative

An expired idys-alif cage was implanted into the patient.This product had expired on 01/15/2023.Clariance notified apex medical regarding the expiration of the device and requested it be returned on 02/02/2023.A representative of apex medical responded on that this specific product (and lot number) 03/01/2023 that this product was not in the posession of apex medical.The cage was subsequently implanted during surgery on (b)(6) 2023.

• Brand Name: IDYS-ALIF
• Type of Device: IDYS-ALIF CAGE 26X32 - H16MM - 14
• 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: 16989321
• MDR Text Key: 315872530
• Report Number: 3009962553-2023-00001
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 03700780626953
• UDI-Public: (01)03700780626953(17)230115(10)H465X-HC02Y
• 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
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 24520614-S
• Device Catalogue Number: 24520614-S
• Device Lot Number: H465X-HC02Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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