BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 4.35MM DOUBLE-LEAD TAP

    MDR report key: 3140608 · Received May 31, 2013

    Report

    Report Number
    1526439-2013-17974
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. A DHR COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER OF THE DEVICE IS UNKNOWN. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IT SHOULD BE NOTED THAT THE SURGEON REPORTED THE PATIENT AS HAVING VERY HARD BONE AS A RESULT OF BONE SCLEROSIS WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT DURING TH3-11 INSTRUMENTATION WITH THE EXPEDIUM SYSTEM, THE SHAFT OF THE DOUBLE LEAD TAP BROKE WHEN TAPPING IN TH10. THE BROKEN PORTION OF THE INSTRUMENT COULD NOT BE REMOVED AND REMAINS IN THE RIGHT SIDE OF TH10. AFFILIATE REPORTS THAT ACCORDING TO THE SURGEON, BONE SCLEROSIS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241081 EXPEDIUM 4.35MM DOUBLE-LEAD TAP TAP, BONE LXH DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention