BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS LONG 3.5 4HO L120 SST

    MDR report key: 3193335 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03150
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    October 21, 2011
    Report Date
    October 25, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WAS TRYING TO LOCK IN A SCREW IN THE LEFT HOLE A PROXIMAL PART OF THE PHILOS PLATE, THE SCREW KEPT SPINNING AND AS SUCH, HE COULD NOT PUT A LOCKING SCREW IN THAT HOLE. IN LIGHT OF THE FACT THAT THIS PATIENT HAS CO-MORBIDITIES, AND IS A HIGH DEPENDENCY UNIT PATIENT, THE SURGEON CHOSE TO LEAVE THIS PLATE IN SO AS TO NOT PROLONG SURGERY TIME. THERE WAS NO IMPACT ON THE HEALTH OF THE PATIENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293436 PHILOS LONG 3.5 4HO L120 SST HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1