BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 5.50 DUAL-INNIE POLYAXIAL SCREW 8.00X100MM, TI

    MDR report key: 2991322 · Received March 6, 2013

    Report

    Report Number
    1526439-2013-13246
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    April 12, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION CONFIRMED THAT THE EXPEDIUM DUAL INNIE POLYAXIAL BROKE AT THE TRANSITION FROM THE SCREW HEAD TO THE SCREW SHANK. A SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED ON THE FRACTURED SURFACES TO FACILITATE A MORE DETAILED INVESTIGATION OF THE FRACTURE CHARACTERISTICS OF THE DAMAGED SAMPLE. RESULTS ACKNOWLEDGED AN EVIDENT FATIGUE STRIATION WHERE THE CRACK TERMINATION TOOK PLACE. FURTHERMORE, THE EXISTENCE OF THE TWO SURFACE MORPHOLOGIES ILLUSTRATED THAT THE FRACTURE FIRST PROPAGATED AND THEN A FULL FAILURE/BREAKAGE TOOK PLACE PRESUMABLY WHEN THE REMAINING REGION DID NOT HAVE STRENGTH TO BEAR THE LOAD. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE SEM FRACTURE ANALYSIS SUGGESTS THAT THE SCREW FRACTURE MOST LIKELY OCCURRED DUE TO FATIGUE. IT WAS REPORTED THAT PATIENT IS A SMOKER AND OVERWEIGHT. IN THE ABSENCE OF A PRODUCT ISSUE 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 RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED TO REMOVE TWO BROKEN SCREWS. PATIENT HAD COMPLAINED OF PAIN AND X-RAYS NOTED BROKEN HARDWARE. SEE MFG MEDWATCH REPORT NO. 1526439-2013-13245, FOR THE OTHER SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95521 EXPEDIUM 5.50 DUAL-INNIE POLYAXIAL SCREW 8.00X100MM, TI ORTHOSIS, SPINAL PEDICLE FIXATION FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE RL146546

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention