BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS ROD Ø6 RAD 200 NORMALISED L120 TI

    MDR report key: 3182999 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03663
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 30, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. VISUAL INSPECTION WAS PERFORMED AND DEVICE MET SPECIFICATIONS. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROD SLIPPED OUT OF SCREW HEAD, THE CLOSING CAP IS PLACED CORRECTLY, AND THE SCREW IS FINE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283189 MIS ROD Ø6 RAD 200 NORMALISED L120 TI HSB SYNTHES GMBH 3514872

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention