MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PXL : 33X36 H 14MM 14 DEG.; ROI-A ALIF CAGE SYSTEM

Catalog Number	IR2741P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the surgeon impacted the anchor plate and the cage broke.The cage was removed and another cage was used to complete the case without any impact on the patient.
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 surgeon impacted the anchor plate and the cage broke.The cage was removed and another cage was used to complete the case without any impact on the patient.
Additional Manufacturer Narrative
Device evaluation: product was not returned, however photos were provided showing the fracture.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient or operational factors.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 33X36 H 14MM 14 DEG.
• 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17133933
• Report Number: 3004788213-2023-00061
• Device Sequence Number: 20445075
• Product Code: MAX
• UDI-Device Identifier: 03662663012010
• UDI-Public: (01)03662663012010(17)240401(10)M55735
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153495
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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 Expiration Date: 03/31/2024
• Device Catalogue Number: IR2741P
• Device Lot Number: M55735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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
• Patient Age: 46 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic