BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-D POSTERIOR I.F. INSTRUMENTS

    MDR report key: 243230 · Received September 29, 1999

    Report

    Report Number
    2246640-1999-00002
    Event Type
    Other
    Date Received
    September 29, 1999
    Date of Event
    August 25, 1999
    Report Date
    September 24, 1999
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP REPORT TO MDR #2246640-1999-2 FILED ON 9/24/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-D POSTERIOR I.F. INSTRUMENTS ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS LXH OSTEOTECH, INC. 00-2114-14, 00-2114-15 12/05/98 FOR 00-2114-15

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention