BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.35MM TI CANCELLOUS EXP HEAD SCREW/SELF-TAP/12MM

    MDR report key: 3082363 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-02233
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    PMA / PMN Number
    K994187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE TABS ON THE SCREW HEAD ARE BENT AND SHOW MARKS OF INADEQUATE AND FORCIBLE USE. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY IMPLANTATION AND EXTRACTION. THE EXPANSION HEAD SCREWS WHICH WERE BENT AT THE TABS MAY HAVE BEEN INSERTED WITH THE DRIVER OFF-AXIS CAUSING A BENDING LOAD ON THE TABS WHICH IS WHY THE TABS ARE NOT BENT SYMMETRICALLY. THE LOCKING SCREW IS USED IN CSLP, CSLP SMALL STATURE, AND CSLPVA CERVICAL PLATES. THE LOCKING SCREW FAILED IN SHEAR AT CROSS SECTION AT A MINOR THREAD DIAMETER JUST BELOW THE HEAD EXPERIENCED DUE TO STRESSES BEYOND THE SHEAR STRENGTH OF THE MATERIAL. THE COMPLAINT DESCRIPTION DOES NOT INCLUDE ENOUGH INFORMATION TO SUGGEST WHAT CONTRIBUTED TO THIS EVENT. THE MATERIALS WERE REVIEWED FOR THE EXPANSION HEAD AND LOCKING SCREWS ARE ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, DURING A CERVICAL FUSION PROCEDURE, THE TABS BENT ON TWO EXPANSION HEAD SCREWS. IT WAS REPORTED THAT A LOCKING SCREW ALSO BROKE AT THE SHAFT INSIDE OF THE THIRD EXPANSION HEAD SCREW. THE SCREW WAS REMOVED AND REPLACED. SURGERY WAS DELAYED BY APPROXIMATELY 15-20 MINUTES. SURGEON COMPLETED THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183974 4.35MM TI CANCELLOUS EXP HEAD SCREW/SELF-TAP/12MM KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR