BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04431

    MDR report key: 3232414 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04431
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    April 1, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 COMMON DEVICE NAME: MNH, MNI, KWQ, KWP.

    Description of Event or Problem · 1

    ONE LOCKING CAP COULD NOT BE LOCKED DURING THE SURGERY. THE SURGEON REMOVED IT AND CHANGED TO A REPLACEMENT UNIT. THREE LOCKING CAPS WERE BLOCKED AND COULD NOT BE LOOSENED, REMOVED, DURING SURGERY WHICH MADE IT IMPOSSIBLE TO RE-CONTOUR THE ROD FOR A BETTER RESULT. THE PATIENT WAS IMPACTED. THE SURGERY WAS DELAYED. THE EVENT DID NOT REQUIRE ADDITIONAL MEDICAL TREATMENT. THIS IS 5 OF 5 REPORTS FOR THIS COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335702 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention