BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-C SHORT ANCHORING PLATE

    MDR report key: 22320288 · Received June 24, 2025

    Report

    Report Number
    3004788213-2025-00036
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 15, 2025
    Report Date
    November 13, 2025
    Manufacturer
    LDR MEDICAL
    Product Code
    OVE
    UDI-DI
    03662663016971
    PMA / PMN Number
    K151934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: PART CMC1342P, LOT C103081 (ROI-C COATED IMPLANT 12X14X6) 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 · 0

    ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. ROOT CAUSE: THIS EVENT COULD BE ATTRIBUTED TO THE PILOT HOLE NOT BEING DRILLED TO THE CORRECT DEPTH INITIALLY, AS REPORTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CAGE INSERTION, A PILOT HOLE WAS DRILLED TO FULL DEPTH WITH AN AWL, BUT THE ANCHORING PLATE WAS NOT ABLE TO GO IN ALL THE WAY. THE PLATE WAS DISCARDED, THE DEPTH WAS ADJUSTED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PLATE WITHOUT RESULTING IN ANY PATIENT HARM, AND ONLY A 10 MINUTE PROCEDURAL DELAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CAGE INSERTION, A PILOT HOLE WAS DRILLED TO FULL DEPTH WITH AN AWL, BUT THE ANCHORING PLATE WAS NOT ABLE TO GO IN ALL THE WAY. THE PLATE WAS DISCARDED, THE DEPTH WAS ADJUSTED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PLATE WITHOUT RESULTING IN ANY PATIENT HARM, AND ONLY A 10 MINUTE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579856 ROI-C SHORT ANCHORING PLATE INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE LDR MEDICAL NA 291411/16 03662663016971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10.