BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM

    MDR report key: 3030060 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01286
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: 08/22/2012. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE VISIBLE INVESTIGATION SHOWS THAT THE THREAD ON THE HEAD IS DAMAGED; THE HEXAGON RECESS SHOWS MARKS OF USE. ALSO THE COMPLETE THREAD ON THE SHAFT IS DAMAGED; THE THREAD FLANKS ARE FLATTENED AND WORN OFF. THE VISIBLE LOT NUMBER IS 8041224. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CAN NOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODES: JDP, HWC. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS IS 2 OF 6 REPORTS FOR (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH VA CONDYLAR PLATE AND SCREWS, DATE UNKNOWN. PATIENT RETURNED TO SURGEON AND COMPLAINED OF LEG SHORTENING, ROTATION. AN X-RAY SHOWED THAT 4 OUT OF THE 5 LOCKING SCREWS WERE LOOSENED AND BACKING OUT OF THE PLATE. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR PLATE SCREW REMOVAL. PATIENT WAS REVISED TO A 4.5MM LCP CURVED CONDYLAR PLATE. THIS IS 2 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134286 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM HRS SYNTHES GMBH 8041224

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention