BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN TO ROD COUPLING

    MDR report key: 1640953 · Received February 5, 2010

    Report

    Report Number
    8031020-2009-00144
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    June 6, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS
    Product Code
    JEC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISION. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008, WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED) AND PRODUCT CODE (B) (4).

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION AS EXPECTED. WHEN THE SURGEON TRIED TO USE THE PIN TO ROD COUPLING, IT DID NOT WORK. (THE SQUARE SCREW HEAD WAS HARD TO TURN, HOWEVER IT WAS A BRAND NEW PRODUCT). THE PROCEDURE WAS COMPLETED WITH ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN TO ROD COUPLING NA JEC STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS NA M17673

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other