BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 5.5 SS SI POLYSCR 7.0 X 45

    MDR report key: 3150584 · Received June 6, 2013

    Report

    Report Number
    1526439-2013-18288
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWP
    PMA / PMN Number
    PK041119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE REP THAT PATIENT WAS (REMOVAL OF SPINE HARDWARE) DUE TO 2 BROKEN PEDICLE SCREWS. ALL HARDWARE WAS REMOVED AND NOT REPLACED. THE SCREWS WERE DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION. THE LOT CODES ARE UNKNOWN. WITHOUT LOT CODES, REVIEWS OF MANUFACTURING RECORDS CANNOT BE COMPLETED. WITHOUT PRODUCT SAMPLES, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. REVIEW OF COMPLAINT DATA FOUND NO EMERGING TRENDS. IN THE ABSENCE OF PRODUCT SAMPLES, LOT NUMBERS, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. DEVICE DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS REVISION SURGERY WAS PERFORMED DUE TO THE BREAKAGE OF TWO PEDICLE SCREWS. ALL HARDWARE WAS REMOVED AND NOT REPLACED. THE DEVICES WERE DISCARDED. SEE MFG MEDWATCH REPORT NO. 1526439-2013-18287 FOR THE OTHER SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250670 EXPEDIUM 5.5 SS SI POLYSCR 7.0 X 45 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention