BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE

    MDR report key: 3060092 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-11083
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    May 25, 2012
    Report Date
    May 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)(4)

    Description of Event or Problem · 1

    MPE (MARKET PREFERENCE EVALUATION) CASE #14 REPORTS THREADS ON PLATE HOLE AND ON VA SCREWS WERE STRIPPED. THE SURGEON ALSO COMPLAINED THAT SCREWDRIVER HAS TOO MUCH TORQUE. IT IS UNKNOWN IF PLATE OR SCREWS WERE UTILIZED OR REPLACED. NO HARM OR POTENTIAL HARM TO PATIENT NOTED ON MPE FORM. THIS IS FROM VA (VARIABLE ANGLE) LCP ELBOW SYSTEM MPE. EVENT #1 OF 3 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163615 PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR