BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.2X7MM BONE SCREWS,CROSS-PIN,SELF-T

    MDR report key: 3200179 · Received July 1, 2013

    Report

    Report Number
    0008010177-2013-00138
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K062498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT IS STILL IMPLANTED IN PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, BECAUSE NEITHER THE COMPLAINED DEVICE WAS RETURNED NOR ENOUGH INFORMATION WAS RECEIVED. THE ROOT CAUSE FOR THE OBSERVED REACTION CANNOT BE DETERMINED. HOWEVER, BECAUSE THE PATIENT¿S POSTOPERATIVE ALLERGY TEST SHOWED A METAL SENSITIVITY THE REACTION MAY HAVE BEEN THE RESULT OF THE PATIENT CONDITION. AS PER STATISTICAL EVALUATION, NO INDICATIONS WERE FOUND FOR ANY DEVICE RELATED ISSUE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT HAD SURGERY ON HER LEFT RING FINGER ON (B)(6) 2013 DUE TO FRACTURE WITH TITANIUM ALLOY SCREWS INSERTED AS WELL. PATIENT ALSO EXPERIENCING PAIN AND INFLAMMATION DURING REHABILITATION.

    Description of Event or Problem · 1

    THE PATIENT HAD SURGERY ON HER LEFT RING FINGER ON (B)(6) 2013 DUE TO FRACTURE WITH TITANIUM ALLOY SCREWS INSERTED AS WELL. PATIENT ALSO EXPERIENCING PAIN AND INFLAMMATION DURING REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299546 1.2X7MM BONE SCREWS,CROSS-PIN,SELF-T IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1