BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4

    MDR report key: 2914604 · Received January 14, 2013

    Report

    Report Number
    2520274-2013-00319
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    February 5, 2010
    Report Date
    February 25, 2010
    Manufacturer
    SYNTHES
    Product Code
    JEY
    PMA / PMN Number
    K022012
    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

    THE (B)(6) REPORTED THAT THE SCREW BROKE DURING FINAL TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21166 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 1.6 NEURO SELF DRILLING SCREW JEY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1