BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM TI CANCELLOUS LOCKING SCREW

    MDR report key: 2041923 · Received March 29, 2011

    Report

    Report Number
    8030965-2011-00122
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 10, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWQ
    PMA / PMN Number
    K022791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ALL LOCKING SCREWS WERE TIGHTENED WITH A TORQUE LIMITER. DURING REVISION SURGERY, FOR AN UNKNOWN REASON, TWO LOCKING SCREWS BECAME JAMMED WITH THE PLATE AND WERE DIFFICULT TO REMOVE. PRESSURE WAS APPLIED TO THE SCREWDRIVER TIP, CAUSING THE SCREWDRIVER TIP TO TWIST AND DEFORMATION OF THE SCREW RECESS. THE PLATE AND SCREWS WERE REMOVED. THIS IS THE 2ND OF 9 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM TI CANCELLOUS LOCKING SCREW CANCELLOUS LOCKING SCREW KWQ SYNTHES BRANDYWINE NA 6488397

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PLATE| SYNMESH| END RING