BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI OBA PLATE ANCHOR BRACKET DESIGN 5 HOLES

    MDR report key: 3070250 · Received April 22, 2013

    Report

    Report Number
    3003506883-2013-10135
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    OAT
    PMA / PMN Number
    K093299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    HOSPITAL ACCOUNT REPORTED DURING A PROCEDURE THE SURGEON WAS BENDING THE PLATE ANCHOR TO CONFORM TO PATIENT'S BONE AND IT BROKE. THE PLATE WAS BEING BENT OVER A TRAY AND NOT THE PATIENT. SURGEON SELECTED A DIFFERENT PLATE AND COMPLETED THE PROCEDURE. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173077 TI OBA PLATE ANCHOR BRACKET DESIGN 5 HOLES OAT SYNTHES ELMIRA 6072250

    Patients

    Seq Age Sex Outcome Treatment
    1