BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW, TI GAMMA3® Ø10.5X90MM

    MDR report key: 3842514 · Received June 2, 2014

    Report

    Report Number
    0009610622-2014-00255
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WAS RETAINED BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE LAG SCREW WAS NOT RETURNED TO STRYKER (B)(4) AS THE ¿PATIENT RETAINED HARDWARE¿ ACCORDING TO INFORMATION RECEIVED. THUS, A PHYSICAL EXAMINATION WAS NOT POSSIBLE. LIKEWISE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE INVESTIGATION REPORT IS BASED ON AVAILABLE INFORMATION, ONLY. FAILURES IN MATERIAL OR MANUFACTURING OF THE REPORTED LAG SCREW WERE NOT FOUND. REFERRING TO THE IMAGE RECEIVED IT CANNOT BE EXCLUDED THAT IN THIS CASE THE LAG SCREW HAD BEEN CHOSEN TOO LONG, WHICH IS SUPPORTED BY THE STATEMENT OF THE SURGEON DURING 4TH FOLLOW UP ON APR 23TH, 2013: ¿IF WE CAN FIND A SCREW SHORT ENOUGH TO JUST REPLACE THIS I WOULD RECOMMEND US TO.¿ HOWEVER, IN ABSENCE OF THE SUBJECT PRODUCT AND BASED ON THE INFORMATION GIVEN THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    REVISED TRAUMA CASE WITH GAMMA LARGE SCREW DUE TO PAINFUL HARDWARE.

    Description of Event or Problem · 1

    REVISED TRAUMA CASE WITH GAMMA LARGE SCREW DUE TO PAINFUL HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321052 LAG SCREW, TI GAMMA3® Ø10.5X90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K896108

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention