BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-C SHORT ANCHORING PLATE

    MDR report key: 12059907 · Received June 24, 2021

    Report

    Report Number
    3004788213-2021-00067
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 3, 2021
    Report Date
    June 24, 2021
    Manufacturer
    LDR MÉDICAL
    Product Code
    OVE
    PMA / PMN Number
    K151934
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 800290 OR 800560. SUMMARY: THE COMPLAINT IS CONFIRMED VIA X-RAY FOR ONE (1) OF ONE (1) ROI-C PLATE (PN MC1005T) FOR THE FAILURE OF POST-OP FRACTURE. MEDICAL RECORDS WERE PROVIDED FOR REVIEW IN THE FORM OF X-RAY AND WERE USED FOR THE EVALUATION. DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED BUT A PHOTOCOPY OF THE X-RAY IS AVAILABLE AND REVIEWED WHICH SHOWS TWO OF THE FRACTURED PLATES ONE AFTER 7 WEEKS AND ANOTHER AFTER 18 WEEKS. DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE: THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO PATIENT CONDITIONS, POST-OP EVENTS SUCH AS TRAUMA OR NOT FOLLOWING POST-OP GUIDANCE, IMPROPER PLATE PLACEMENT, OR SURGICAL EVENTS NOT COMMUNICATED BY THE COMPLAINANT. DHR REVIEW AND RELATED ACTIONS PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE 18 WEEK POST-OP FOLLOW UP APPOINTMENT, THE SURGEON DISCOVERED ANOTHER PLATE WAS FRACTURED. THE PATIENT IS IN GOOD CLINICAL CONDITION AND THERE IS NO REVISION SURGERY PLANNED AT THIS TIME. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952892 ROI-C SHORT ANCHORING PLATE ROI-C TITANIUM-COATED IMPLANT SYSTEM OVE LDR MÉDICAL N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1