BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L16 TAN

    MDR report key: 3192972 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03668
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 3, 2012
    Report Date
    April 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW RAN THROUGH THE PLATE AT THE MOST DISTAL SIDE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293885 VA LOCKSCR Ø2.4 SELF-TAP L16 TAN HWC SYNTHES GMBH 7711406

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR