BEUDAMED
    FDA Adverse Event Other Summary report: N

    EBI

    MDR report key: 494865 · Received October 30, 2003

    Report

    Report Number
    MW1030046
    Event Type
    Other
    Date Received
    October 30, 2003
    Date of Event
    October 20, 2003
    Manufacturer
    EBI, L.P.
    Product Code
    JDN
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REMOVING EBI SPINAL HARDWARE. EBI REP PRESENT. 3 OF 4 EXPANDABLE OMEGA 21 SCREWS BROKE DURING REMOVAL. ATTEMPTS MADE TO REMOVE PIECES LEFT IN PT WERE UNSUCCESSFUL. NO HARM TO PT. CAT SCAN ORDERED TO CONFIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI 7/40 EXPANDABLE SCREW JDN EBI, L.P. 128840 02053769
    10 EBI LOCK NUT JDN EBI, L.P. 128403 611753
    11 EBI MULTI-DIRECTIONAL COMPLEX JDN EBI, L.P. 128007 01101275
    12 EBI MULTI-DIRECTIONAL COMPLEX JDN EBI, L.P. 128007 01101275
    13 EBI MULTI-DIRECTIONAL COMPLEX JDN EBI, L.P. 128007 01101275
    14 EBI MULTI-DIRECTIONAL COMPLEX JDN EBI, L.P. 128007 01101275
    15 EBI 15CC OSTEOSTIM JDN EBI, L.P. 9025 343370
    2 EBI 7/40 EXPANDABLE SCREW JDN EBI, L.P. 128840 02053769
    3 EBI 7/40 EXPANDABLE SCREW JDN EBI, L.P. 128840 02053769
    4 EBI 8/40 EXPANDABLE SCREW JDN EBI, LP 129140 02013523
    5 EBI 50MM ROD JDN EBI, LP 128305 00061373
    6 EBI 50MM ROD JDN EBI, L.P. 128305 00061373
    7 EBI LOCK NUT JDN EBI, L.P. 128403 611753
    8 EBI LOCK NUT JDN EBI, L.P. 128403 611753
    9 EBI LOCK NUT JDN EBI, L.P. 128403 611753

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other