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

Model Number	24520614-S
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 an expired cage was implanted into a patient during surgery.
Additional 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
• Common Device Name: 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
• Report Number: 3009962553-2023-00001
• Device Sequence Number: 6828858
• Product Code: OVD
• UDI-Device Identifier: 03700780626953
• UDI-Public: (01)03700780626953(17)230115(10)H465X-HC02Y
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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