BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM 5.50 POLYAXIAL SCREW 7X50, TI

    MDR report key: 1812117 · Received August 17, 2010

    Report

    Report Number
    1526439-2010-00115
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K062174
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTS HAVE NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. WHEN RETURNED AN EVALUATION SHALL BE COMPLETED.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT DURING SURGERY, THE SURGEON WAS UNABLE TO PLACE THE SETSCREW INTO THE SCREW HEAD TO SECURE THE CONSTRUCT. SEVERAL WERE TRIED WITH THE SAME RESULT. HE REMOVED THE SCREW AND USED ANOTHER SETSCREW AND IT WORKED PROPERLY. THE EVENT DID NOT IMPACT THE PATIENT. AS THE DELAY IN THE CASE WAS IN EXCESS OF 30-MIN. AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM 5.50 POLYAXIAL SCREW 7X50, TI SPINAL FIXATION DEVICE MNH DEPUY SPINE, INC. NA AJJBHC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT: ALGDKL| SETSCREW: (B)(4) (QTY 3), LOT: ALDC3C| LOT: AKHCLN