BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE PELVIS KIT HOFFMANN II 4MM APEX

    MDR report key: 1632509 · Received March 3, 2010

    Report

    Report Number
    8031020-2010-00028
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 12, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JEC
    PMA / PMN Number
    K952730
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING PELVIS SURGERY, WHEN THE ROD COUPLING IN DISPOSABLE PELVIS KIT (STERILED) WAS USED, ONE OF THE SCREW FOR THE ROD COUPLING WAS TIGHT AND DID NOT FUNCTION. THE SURGEON CHANGED HOW TO ASSEMBLE FRAME AND THE FRAME FIXED WITHOUT PROBLEM. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE PELVIS KIT HOFFMANN II 4MM APEX IMPLANT JEC STRYKER OSTEOSYNTHESIS SELZACH NA U03065

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other