BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SI POLYAXL SCREW 5 X 40MM

    MDR report key: 3132528 · Received May 29, 2013

    Report

    Report Number
    1526439-2013-17694
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    January 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREWS WERE DISCARDED BY THE CUSTOMER AND ARE NOT AVAILABLE FOR ANALYSIS. REVIEWS OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED AS THE LOT CODES ARE UNKNOWN. REVIEWS OF PRODUCT COMPLAINTS FOUND NO EMERGING TREND, WITHOUT PRODUCT SAMPLES, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLES, LOT NUMBERS, OR AN EMERGING TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. DEVICES DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    PATIENT HAD PRIOR BACK SURGERIES AND HAD SEVERE PAIN. RE-FUSION WAS PERFORMED ON (B)(6) 2013 REMOVING IMPLANTS AT TH 12 AND L1 AND EXTENDING THE FUSION TO TH7. FOUR POLYAXIAL SCREWS THAT WERE REMOVED FROM TH12 AND CD L1 WERE FOUND TO HAVE TOTALLY LOOSENED. THE SCREWS WERE DISCARDED BY THE CUSTOMER. THIS MEDWATCH REPORT IS BEING FILED FOR THE FOUR EXPEDIUM POLYAXIAL SCREWS THAT HAD LOOSENED. ALL ARE CATALOG NUMBER 179712540, LOT NUMBERS ARE UNKNOWN. SEE MFG MEDWATCH REPORT NO'S. 1526439-2013-17563, 1526439-2013-17565, 1526439-2013-17566 FOR A MORE RECENT EVENT INVOLVING THIS SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234293 EXPEDIUM SI POLYAXL SCREW 5 X 40MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention