BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L24 SST

    MDR report key: 3750256 · Received April 15, 2014

    Report

    Report Number
    1000562954-2014-10048
    Event Type
    Injury
    Date Received
    April 15, 2014
    Report Date
    March 17, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    KTT
    PMA / PMN Number
    PK000684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PT AGE: DATE OF BIRTH REPORTED AS (B)(6). COMMON DEVICE NAME: ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES: HWC. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A REVISION SURGERY TO REMOVE TWO BROKEN SCREWS. BREAKAGE OF THE BLOCKAGE SCREW OCCURRED 37 DAYS AFTER THEY WERE IMPLANTED IN THE PATIENT. A SECOND SURGERY AT AN UNKNOWN DATE WAS NECESSARY TO REPLACE BOTH SCREWS. THIS REPORT IS FOR 2 OF 2 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229370 LOCKSCR Ø3.5 SELF-TAP L24 SST APPLIANCE,FIXATION,NAIL KTT SYNTHES MEZZOVICO 8286936

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention