BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L20 SS

    MDR report key: 2940974 · Received February 4, 2013

    Report

    Report Number
    1719045-2013-00221
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    October 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K100776
    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. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THAT SYNTHES WAS UNABLE TO CHECK THE MEASURABLE DIMENSIONS FOR THIS ITEM AS LOTS ARE UNKNOWN. THE IMPLANT HAS NOT FAILED, IT WAS MERELY SENT BACK AFTER THE REVISION DUE TO THE NON UNION. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A SURGEON IN (B)(6) ADVISED A PATIENT UNDERWENT A BILATERAL 1ST MTP FUSION USING A 1ST MTP 0 DEGREE SMALL LEFT AND RIGHT ON (B)(6) 2012. ON A FOLLOW-UP VISIT THE SURGEON NOTED THAT THE FUSION IS NOT SHOWING SIGNS OF UNION IN THE RIGHT FOOT. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND ALL HARDWARE WAS EXPLANTED. SURGEON INDICATED THAT MAYBE SHE DIDN'T FUSE BECAUSE SHE IS RHEUMATOID AND IS ON IMMUNO-SUPPRESSANTS. THIS IS 7 OF 8 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46201 VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L20 SS LOCKING SCREW HRS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention