MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PXL : 30X33 H 14MM 14; ROI-A ALIF CAGE SYSTEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that when trying to impact an anchoring plate, the implant holder became disengaged from the implant and it was impossible to reposition the implant holder on the cage.The cage fractured.There was no reported patient impact.
Additional Manufacturer Narrative
Inspection: the returned item was evaluated.Visual inspection reveals that the cage is fractured.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis or excessive forces applied during use.Device usage this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that when trying to impact an anchoring plate, the implant holder became disengaged from the implant and it was impossible to reposition the implant holder on the cage.The cage fractured.There was no reported patient impact.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 30X33 H 14MM 14
• Common Device Name: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, n/a 10300 ; FR 10300
• MDR Report Key: 11842153
• Report Number: 3004788213-2021-00051
• Device Sequence Number: 3142508
• Product Code: MAX
• UDI-Device Identifier: 03662663011723
• UDI-Public: (01)03662663011723(17)240901(10)19-327221
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 09/01/2024
• Device Model Number: N/A
• Device Catalogue Number: IR2641P
• Device Lot Number: 19-327221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 70