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

Catalog Number	IR2422P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a roi-a cage fractured while being implanted.It remains implanted, but the plates were unable to be installed.There was a delay of 15 minutes, but there were no reported patient impacts.
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.
Additional Manufacturer Narrative
Corrections in d4: expiration date and udi number.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: product not returned and no photos or x-rays were provided.Device evaluation unable to be completed.Root cause: root cause was unable to be determined.This event could possibly be attributed to off-axis insertion of the plates.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a roi-a cage fractured while being implanted.It remains implanted, but the plates were unable to be installed.There was a delay of 15 minutes, but there were no reported patient impacts.

• Brand Name: ROI-A MEDIAN IMPLANT PXL: 23X26 H 10MM 6 DEGREES
• Common Device Name: 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16023431
• Report Number: 3004788213-2022-00127
• Device Sequence Number: 12227072
• Product Code: MAX
• UDI-Device Identifier: 03662663011068
• UDI-Public: (01)03662663011068(10)L190068
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2023

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: 11/01/2024
• Device Catalogue Number: IR2422P
• Device Lot Number: L190068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• 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