BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES USA

    MDR report key: 410592 · Received August 5, 2002

    Report

    Report Number
    MW1025851
    Event Type
    Injury
    Date Received
    August 5, 2002
    Date of Event
    July 27, 2002
    Report Date
    August 5, 2002
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD INTERTROCHANTERIC SIDE PLATE PUT IN RIGHT HIP - FEMUR - AS PART OF PINNING PROCESS IN 2002. PT WAS DISCHARGED TO SNF FOR PHYSICAL THERAPY AND REHABILITATION THEREAFTER FOR A FEW WEEKS AND ULTIMATELY HOME. PT WAS AT HOME FOR APPROX ONE MONTH AND NOTICED SOME HIP PAIN IN 7/02. PT WENT TO BED AND WOKE UP LATE EVENING WITH SEVERE PAIN. AN X-RAY PERFORMED DURING THE SUBSEQUENT ER VISIT REVEALED A COMPLETE FRACTURE OF THE PLATE AT THE NECK OF THE 2ND PROXIMAL SCREW THROUGH THE 3RD SCREW HOLE IN THE PLATE. SURGERY WAS SUCCESSFULLY PERFORMED THE NEXT DAY TO REMOVE THE DEFECTIVE PLATE AND A REPLACEMENT PLATE WAS INSERTED. THE PT WAS DISCHARGED FROM THE HOSP TO THE SNF TO REINITIATE REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA INTERTROCHANTERIC SIDE PLATE HRS SYNTHES USA 316 L *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R REPLACED WITH SYNTHES SIDE PLATE CAT# 281.98S,| MCN# 4239669, MAT# 316L.