MAUDE Adverse Event Report: LDR MEDICAL ROI-A MEDIAN IMPLANT PXL : 23X26 H 12MM 10 DEG.; ROI-A ALIF CAGE SYSTEM

Catalog Number	IR2433P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient had alif surgery and had a median roi-a device implanted in the spine.After the surgery and checkup with x-rays, it was shown that one of the blades on the device was fractured in half.There was no reported patient impact and the implant remains implanted with no revision surgery planned at this time.
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 a patient had alif surgery and had a median roi-a device implanted in the spine.After the surgery and checkup with x-rays, it was shown that one of the blades on the device was fractured in half.There was no reported patient impact and the implant remains implanted with no revision surgery planned at this time.
Additional Manufacturer Narrative
Additional information in d4: expiration date & udi number, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: product not returned, however x-rays were provided.The x-ray shows the plate fracture in-situ.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient, operative or traumatic factors.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s 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.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 23X26 H 12MM 10 DEG.
• Common Device Name: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17711770
• Report Number: 3004788213-2023-00073
• Device Sequence Number: 6749385
• Product Code: MAX
• UDI-Device Identifier: 03662663011136
• UDI-Public: (01)03662663011136(17)251101(10)L201223
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: Lay User/Patient
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: IR2433P
• Device Lot Number: L201223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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: Male
• Patient Ethnicity: Non Hispanic