BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTRACTION ROD FOR 18MM FRAME, L

    MDR report key: 140438 · Received December 18, 1997

    Report

    Report Number
    8010177-1997-00073
    Event Type
    Injury
    Date Received
    December 18, 1997
    Date of Event
    July 1, 1997
    Report Date
    December 17, 1997
    Manufacturer
    HOWMEDICA INC
    Product Code
    JEY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: EVAL RESULTS INDICATE THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVIE BUT RATHER WOULD BE REALTED TO USER TECHNIQUE. ADDED INFO: UPDATED INFO IN THE FOLLOWING SECTIONS: B2,B3,B5,D1,D6(CATALOG #), D7,D8,D9, AND E1. ALSO, SECTION H1 HAS BEEN CHANGED TO SERIOUS INJURY DUE TO SURGICAL DELAY. THIS IS THE SAME PT/EVENT AS MFR # 8010177-1998-00039.

    Description of Event or Problem · 1

    ADD'L INFO REVEALED THAT TWO RAMUS DOUBLE JOINT DISTRACTION RODS BROKE AFTER IMPLANTATION WHILE THEIR FUNCTION WAS BEING TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTRACTION ROD FOR 18MM FRAME, L Implant OTHER JEY HOWMEDICA INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other