BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPTR

    MDR report key: 1111764 · Received July 28, 2008

    Report

    Report Number
    MW5007971
    Event Type
    Injury
    Date Received
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    SYNTHES SPINE
    Product Code
    KWP
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WOUND INFECTION POST SURGERY. THERE WERE 2 PATIENTS INVOLVED. BOTH OF THEM WERE EXPLANTED AND REIMPLANTED.

    Description of Event or Problem · 2

    WOUND INFECTION POST SURGERY. THERE WERE 2 PATIENTS INVOLVED. BOTH OF THEM WERE EXPLANTED AND REIMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPTR VERTICAL EXPANDABLE PROSTHETIC TITANIUM ROPE KWP SYNTHES SPINE
    2 ZEPTR VERTICAL EXPANDABLE PROSTHETIC TITANIUM ROPE KWP SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization
    2 9 YR Hospitalization