BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04457

    MDR report key: 3231272 · Received July 17, 2013

    Report

    Report Number
    2520274-2013-04457
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 2, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THREE LOCKING CAPS WERE BLOCKED AND COULD NOT BE LOOSENED/REMOVED DURING SURGERY. REPORTEDLY, THE SCREWS AND RODS ARE NO PROBLEM. THE PATIENT WAS IMPACTED. THE SURGERY WAS DELAYED BY AN UNKNOWN AMOUNT. THE EVENT DID NOT REQUIRE ADDITIONAL MEDICAL TREATMENT. THIS REPORT IS FOR THREE UNKNOWN PEDICLE SCREWS. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331758 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR