BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1/3-TUB-PL 3.5 10HO L124 TI

    MDR report key: 3111796 · Received May 14, 2013

    Report

    Report Number
    2520274-2013-02535
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    June 29, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, IT WAS DISCOVERED SCREW HEAD DAMAGED (HEXAGON SOCKET) ALONG WITH PLATE. THE SURGEON DECIDED TO LEAVE BOTH SCREW AND PLATE IN PATIENT, AND WHERE A REVISIONS SURGERY (DATE UNKNOWN) IS TO BE PERFORMED TO REMOVE IMPLANTS. IT WAS ALSO REPORTED PATIENT DOES NOT EXPERIENCE ANY PAIN. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 1/3-TUB-PL 3.5 10HO L124 TI. THIS IS 1 OF 2 DEVICES FOR THIS EVENT REPORTED ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213265 1/3-TUB-PL 3.5 10HO L124 TI HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention