MAUDE Adverse Event Report: LDR MÉDICAL ROI-A WIDE IMPLANT PXL : 27X36 H 16MM 14; ROI-A ALIF CAGE SYSTEM

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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 the plate would not advance due to the patient's hard bone and it cracked.The surgeon removed the plate and attempted to use the awl to create a pathway for the plate.A second cage was used to complete the case.There were no patient impacts or surgical delays reported.
Additional Manufacturer Narrative
Inspection: visual inspection of the returned devices reveals that the plate is jammed inside the cage and the cage is deformed and fractured around the plate interface.Dhr review: the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.It was mentioned that the patient had hard bone, which may have contributed to this failure.Device usage: this device is used for treatment.Reference report 3004788213-2021-00090.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that the plate would not advance due to the patient's hard bone and the cage cracked.The surgeon removed the plate and cage and attempted to use the awl to create a pathway for the plate.A second cage and plate were used to complete the case.There were no patient impacts or surgical delays reported.Device evaluation by the manufacturer found the plate had jammed inside the cage.This is report one of two for this event.

• Brand Name: ROI-A WIDE IMPLANT PXL : 27X36 H 16MM 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: 12044370
• Report Number: 3004788213-2021-00066
• Device Sequence Number: 19833503
• Product Code: MAX
• UDI-Device Identifier: 03662663013826
• UDI-Public: (01)03662663013826(17)250301(10)L190461
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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 Model Number: N/A
• Device Catalogue Number: IR5245P
• Device Lot Number: L190461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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 Weight: 132