MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE M; ROI-A ALIF CAGE SYSTEM

Catalog Number	IR2008T
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
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 while the surgeon was installing the first plate intra-operatively, the plate would not fully advance.So the surgeon tried to remove it utilizing the removal hook, but the tip of the removal hook broke off.The surgeon was unable to remove the plate, but was able to further impact it into place so that locked into the cage.
Additional Manufacturer Narrative
Device evaluation: product was not returned and no photos were provided.Device evaluation unable to be completed.Root cause: root cause was unable to be determined.This event could possibly be attributed to not using the starter awl or attempting to insert the plate off-axis.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 while the surgeon was installing the first plate intra-operatively, the plate would not fully advance.So the surgeon tried to remove it utilizing the removal hook, but the tip of the removal hook broke off.The surgeon was unable to remove the plate, but was able to further impact it into place so that locked into the cage.

• Brand Name: ROI-A ANCHORING PLATE M
• 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: 16582657
• Report Number: 3004788213-2023-00023
• Device Sequence Number: 19257421
• Product Code: MAX
• UDI-Device Identifier: 03662663010986
• UDI-Public: (01)03662663010986(17)270501(10)289756/6
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153495
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: Other
• Device Catalogue Number: IR2008T
• Device Lot Number: 289756/6
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IG018R REMOVAL HOOK.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic