MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PXL : 23X26 H 10MM 6; ROI-A ALIF CAGE SYSTEM

Model Number	N/A
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.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 during surgery the cage cracked while the plate was being installed.The surgeon removed the plate and cage and replaced them with alternates to finish the procedure.There was no impact on the patient.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the complaint is confirmed for cage fracture.Potential cause: root cause was unable to be determined.This event could possibly be attributed to the plate being misaligned.Dhr review: per the dhr review, the parts were likely conforming when they left zimmer biomet control.Device use: 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 during surgery the cage cracked while the plate was being installed.The surgeon removed the plate and cage and replaced them with alternates to finish the procedure.There was no impact on the patient.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 23X26 H 10MM 6
• 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: 11436917
• Report Number: 3004788213-2021-00025
• Device Sequence Number: 17025001
• Product Code: MAX
• UDI-Device Identifier: 03662663011068
• UDI-Public: (01)03662663011068(17)221101(10)17-190124
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/21/2021

1 Device 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: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR2422P
• Device Lot Number: 17-190124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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