BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE OTIS-C PLUS RIGHT

    MDR report key: 8627884 · Received May 21, 2019

    Report

    Report Number
    3004549189-2019-00082
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    December 30, 2014
    Report Date
    May 17, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    HRS
    PMA / PMN Number
    K120818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. THIS INCIDENT OCCURED IN (B)(6). A DECLARATION HAD BEEN FORMALIZED TO (B)(6) ON FEBRUARY 2015. PATIENT SENSITIVITY/KNOWN COMPLICATION. THIS INCIDENT REMAINS VERY ISOLATED. TO DATE, NO COMPLICATIONS OBSERVED: THE PATIENT IS BETTER. NO CORRECTIVE ACTION IMPLEMENTED.

    Description of Event or Problem · 1

    (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. "SUSPECTED ALLERGIC REACTION 15 DAYS AFTER IMPLANTATION OF : A PLATE EVO9067522 - LOT 142149 AND SCREWS EVO9066045 - LOT 142616; EVO9066050 - LOT 142235; EVO9066045 - LOT 142139 (X2)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420423 PLATE OTIS-C PLUS RIGHT METALLIC PLATE HRS S.B.M. SAS 142149

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other