BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-C IMPLANT, UNKNOWN SIZE

    MDR report key: 9667874 · Received February 4, 2020

    Report

    Report Number
    3004788213-2020-00015
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    September 1, 2016
    Report Date
    February 4, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    OVE
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME IS SIMILAR TO ROI-C TITANIUM-COATED IMPLANT SYSTEM 510K IS SIMILAR TO K151934 THE DEVICE INFORMATION IS UNKNOWN, SO THE SPECIFIC COMMON DEVICE NAME AND 510(K) NUMBER CANNOT BE DETERMINED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAGE BROKE INTRA-OP. UNKNOWN SURGICAL INTERVENTION WAS PERFORMED DURING THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127468 ROI-C IMPLANT, UNKNOWN SIZE SEE H10 OVE LDR MEDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1