BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1061168 · Received May 27, 2008

    Report

    Report Number
    1061168
    Date Received
    May 27, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 27, 2008
    Manufacturer
    SYNTHES USA, INC.
    Product Code
    HWC
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD ORIF SURGERY. DUE TO PATIENT'S INCREASING PAIN, DEVICES WERE REMOVED 17 MONTHS LATER. PRE-OP DIAGNOSIS WAS NON-UNION WITH HARDWARE FRACTURE.

    Description of Event or Problem · 1

    PATIENT HAD ORIF SURGERY. DUE TO PATIENT'S INCREASING PAIN, DEVICES WERE REMOVED 17 MONTHS LATER. PRE-OP DIAGNOSIS WAS NON-UNION WITH HARDWARE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SCREW CORTEX SS 4.5 X 34MM HWC SYNTHES USA, INC. * *
    10 * SLEEVE SET LXH STRYKER ORTHOPAEDICS * 11804502
    2 * SCREW CORTEX SS 4.5 X 26MM HWC SYNTHES USA, INC. * *
    3 * SCREW CORTEX SS 4.5 X 44MM HWC SYNTHES USA, INC. * *
    4 * SCREW CORTEX SS 4.5 X 42MM HWC SYNTHES USA INC * *
    5 * SCREW CORTEX SS 4.5 X 36MM HWC SYNTHES USA, INC * *
    6 * COMPRESSING SCREW 19MM HWC SMITH & NEPHEW, INC. * 07GT11053
    7 * PLATE 135 DEG 6H HRS SMITH & NEPHEW, INC. * 04GT82095
    8 * CABLE 2.0 X 650MM DALL-MILES JDQ STRYKER ORTHOPAEDICS * 19854002
    9 * LAG SCREW 85MM REGULAR HWC SMITH & NEPHEW, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR