BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø5 SELF-TAP L44 TAN

    MDR report key: 3419462 · Received October 18, 2013

    Report

    Report Number
    2520274-2013-06858
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    September 19, 2013
    Report Date
    September 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K962011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL 510K NUMBER K000682. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE RESULTS OF THE ADDITIONAL EVALUATION SHOW THAT THE BROKEN SURFACE IS HOMOGENOUS, WHAT INDICATES MATERIAL CONFORMITY. THIS WAS A PLANNED REVISION DUE TO POOR BONE QUALITY. THEREFORE WE CAN SAY THAT A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED AND IN ALL LIKELIHOOD THE SCREW BROKE DURING THE REMOVAL PROCESS. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS REPORT IS ON A SCREW, UNKNOWN PART AND LOT NUMBER, TOMOFIX SYSTEM. WITHOUT A PART NUMBER THE 510K NUMBER CANNOT BE PROVIDED. 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)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED ON (B)(6) 2013: LATERAL CLOSING WEDGE, DISTAL FEMUR WITH SYNTHES TOMOFIX SYSTEM, PLATE UNKNOWN, AND SCREW, UNKNOWN. IT WAS REPORTED THE FIXATION HAD FAILED AND PATIENTS OSTEOTOMY WAS UNSTABLE. PATIENT HAD A REVISION OPERATION ON (B)(6) 2013 TO REMOVE THE FAILED PLATE / SCREW CONSTRUCT WITH REVISING THE PATIENT TO A LONGER PLATE/ SCREW CONSTRUCT AND MOVING MORE DISTAL ON THE FEMUR. IT WAS REPORTED: THAT THEY DID NOT REALIZE HOW POOR THE PATIENTS BONE QUALITY WAS AND THAT THEY NEEDED TO BE MORE DISTAL WITH PLATE/SCREW FIXATION. THEY ARE UNABLE TO ATTRIBUTE THE FAILURE TO A SPECIFIC FACTOR. THIS REPORT IS ON THE UNKNOWN SCREW. THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE SURGERY WAS A REVISION. THE PATIENT IS IN GOOD CONDITION WITH NO FURTHER COMPLICATIONS WITH REVISION PROCEDURE AT THIS STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535017 LOCKSCR Ø5 SELF-TAP L44 TAN KTT SYNTHES GMBH 2793222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention