BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø5 SELF-TAP L60 TAN

    MDR report key: 2983418 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-00695
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    September 14, 2012
    Report Date
    February 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODE: HWC. THE FAILURE OF THE INVESTIGATED LOCKING SCREWS WAS DUE TO DYNAMIC BENDING LOADS, WHICH LED TO OVERLOAD AND MATERIAL FATIGUE. THE MEASURABLE DIMENSIONS OF THE SCREWS MET SPECIFICATIONS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE INVESTIGATED IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES THAT HAVE BEEN GREATER THAN THE TOLERABLE LOAD. POSTOPERATIVE ACTIVITIES OF THE PATIENT IN COMBINATION WITH INSTABILITY OF THE FRACTURE SITUATION MAY HAVE PLAYED A CERTAIN ROLE TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING A REVISION SURGERY REQUIRED FOR A PATIENT, FOLLOWING AN INITIAL TIBIAL OSTEOTOMY SURGERY. THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2012. POSTOPERATIVELY, THE PATIENT FOLLOWED A GRADUAL WEIGHT BEARING SCHEDULE. 8 WEEKS POSTOPERATIVELY, XRAYS REVEALED THAT THE FOUR PROXIMAL SCREWS WERE BROKEN. ON (B)(6) 2013, XRAYS REVEALED A LATERAL CORTICAL BONE FRACTURE AND LOSS OF ALIGNMENT. REVISION SURGERY TOOK PLACE ON (B)(6) 2013 TO REMOVE THE HARDWARE AND PERFORM BONE REMODELING AND REALIGNMENT. THIS IS REPORT NUMBER 3 OF 4 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS 3 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86059 LOCKSCR Ø5 SELF-TAP L60 TAN LOCKING SCREW KTT SYNTHES GMBH 2810647

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention