BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI OBLIQUE L-PLATE

    MDR report key: 482221 · Received September 9, 2003

    Report

    Report Number
    3003506883-2003-00009
    Event Type
    Injury
    Date Received
    September 9, 2003
    Date of Event
    August 13, 2002
    Report Date
    August 11, 2003
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH PLATES AND SCREWS FOR A LEFORT I MAXILLARY OSTEOTOMY. INVERTED L MANDIBULAR OSTEOTOMIES AND CORRECTION OF NASAL DEVIATION IN 2002. 15 DAYS LATER PT DEVELOPED A POST-OPERATIVE INFECTION ON THE LEFT SIDE. DURING SURGERY THE FOLLOWING MONTH, HARDWARE WAS REMOVED (BILATERALLY), PLACEMENT OF DRAINS R AND L MANDIBLE (L SIDE FRACTURE AT JUNCTURE OF HORIZONTAL AND VERTICAL OSTEOTOMY CUTS WITH LARGE FRAGMENT OF NECROTIC BONES WAS REMOVED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5MM TI OBLIQUE L-PLATE L-PLATES HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention L-PLATES, SCREWS.