BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USS-II PEDICLESCR Ø6.2 L50 DUAL OPEN DOU

    MDR report key: 2875361 · Received December 17, 2012

    Report

    Report Number
    2520274-2012-03992
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    April 6, 2010
    Report Date
    January 1, 2010
    Manufacturer
    SYNTHES
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ACTUAL AWARENESS DATE NOT KNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 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 BREAKAGE OF A PEDICLE SCREW. THE PATIENT REPORTED HE HAD REVISION SURGERY DUE TO THE PEDICLE SCREW BREAKING POST-OPERATIVELY. ACCORDING TO THE PATIENT, THE HOSPITAL REPORT STATED THERE WAS A BREAKAGE OF THE LEFT PEDICLE SCREW L5 WITH CAPILLARY LYSIS MARKS AROUND THE SCREWS LWK2 - LWK5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USS-II PEDICLESCR Ø6.2 L50 DUAL OPEN DOU USS-II PEDICLESCR Ø6.2 L50 DUAL KWP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention