MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE M; AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM,

Catalog Number	IR2008T
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned plate was found to be jammed within the mating plate.The cause cannot be determined, but the patient's hard bone may have contributed to this event.The dhr was reviewed, but there were no indications of manufacturing issues found that would have contributed to this event.This device is used is used for treatment.If additional information is received that changes the information provided in this report, a follow-up report will be submitted.
Event or Problem Description
It was reported that an anchoring plate would not advance due to the patient's hard bone during surgery.However, device evaluation by zimmer biomet personnel found that the anchoring plate was jammed in the mating cage.A new device was used to complete the procedure without patient impacts.

• Brand Name: ROI-A ANCHORING PLATE M
• Common Device Name: AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM,
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 11863109
• Report Number: 3004788213-2021-00058
• Device Sequence Number: 4414694
• Product Code: MAX
• UDI-Device Identifier: 03662663010986
• UDI-Public: (01)03662663010986(17)250301(10)796310
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2025
• Device Catalogue Number: IR2008T
• Device Lot Number: 796310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 49