BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 249996 · Received November 17, 1999

    Report

    Report Number
    249996
    Event Type
    Injury
    Date Received
    November 17, 1999
    Date of Event
    October 13, 1999
    Report Date
    October 18, 1999
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A BICYCLE ACCIDENT ON 7/26/99. SHE WAS SEEN IN ER WITH MARKED AMOUNT OF PAIN AND BONE FRAGMENTS PROTRUDING. X-RAY REVEALED COMMINUTED FRACTURE OF MIDSHAFT OF CLAVICLE. IN 1999, PT HAD OPEN REDUCTION WITH INTERNAL FIXATION OF RIGHT CLAVICLE USING SYNTHES PLATE SYSTEM. TWO MAJOR FRAGMENT WERE APPROXIMATED BUT IN BETWEEN, THE AREA WAS QUITE COMMINUTED. REASSEMBLED PIECES, USED TEMPLATE TO DETERMINE DIRECTION OF PLATE. AFTER DOING THIS, BENT A 3.5 PELVIC RECONSTRUCTION PLATE TO FIT. X-RAY CONFIRMED REDUCTION BEING ANATOMIC. STERILE DRESSING, STERILE CAST PADDING AND A SLING WAS APPLIED. PT WAS DISCHARGED ON 7/30/99 WITH INSTRUCTIONS TO WEAR IMMOBILIZER AND NOT TO LIFT RIGHT ARM. PT WAS READMITTED IN 1999 FOR NONUNION OF RIGHT CLAVICLE. SHE HAD REMOVAL OF DEEP HARDWARE BY OPEN REDUCTION AND INTERNAL FIXATION USING BONE GRAFT FROM RT ANTERIOR ILIAC CREST. IT WAS NOTED THAT THE PLATE WAS NOT BROKEN. ONE SCREW WAS PULLED OUT PROXIMALLY - THE PLATE WAS REMOVED AND REPLACED WITH A 3.5 DYAMIC COMPRESSION PLATE. PT WAS DISCHARGED ON 10/15/OO. X-RAYS PER DR'S OFFICE EXHIBITED DEFINITE BEND IN PLATE OVER THE ENSUING MONTHS; SEVERAL SCREWS APPEARED TO HAVE PULLED LOOSE AND NO EVIDENCE OF UNION OF FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES Implant PELVIC RECONSTRUCTION PLATE HWC SYNTHES 8-HOLE STRAIGHT PELVIC *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 1. SCREWS: 3.5 CORTEX 12MM 204.012 X5,| 2. SCREWS: 3.5 CORTEX 14MM 204.014 X3.