BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USS-II PEDICLESCR Ø6.2 L55 DUAL OPEN DOU

    MDR report key: 3193217 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03848
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    January 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE HISTORY RECORD REVIEW: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE EXAMINATION CARRIED OUT BASED UPON THE MANUFACTURING AND MATERIAL DOCUMENTS SHOWED THAT THE EXISTING PEDICLE SCREW AND SCREW HOLDER WERE MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SLEEVE AND NUT WERE NOT SUBMITTED FOR INVESTIGATION, THEREFORE, NO OPINION CAN BE MADE WITH REGARD TO THE FUNCTIONAL ERROR INDICATED. NO PRECISE CAUSE OF DAMAGE CAN BE DETERMINED FOR THE JAMMING OF THE SCREW HOLDER. THE ARTICLE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PART WAS JAMMED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293959 USS-II PEDICLESCR Ø6.2 L55 DUAL OPEN DOU HWC SYNTHES GMBH 7545179

    Patients

    Seq Age Sex Outcome Treatment
    1