BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    MDR report key: 2960566 · Received February 14, 2013

    Report

    Report Number
    2520274-2013-00899
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    SYNTHES
    Product Code
    KWP
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A CAP COULD NOT BE INSERTED INTO THE SCREW. THE SCREW COULD BE INSERTED NORMALLY BUT TURNED 90 DEGREES. THE ROD COULD NOT BE INSERTED DEEP ENOUGH. THE CAP COULD NOT BE FIXED. IT WAS REPLACED BY ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64262 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH 6.0MM TI MATRIX POLYAXIAL SCREW KWP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1