BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREWS

    MDR report key: 1982276 · Received February 1, 2011

    Report

    Report Number
    1719045-2011-00032
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    ODP
    PMA / PMN Number
    K073541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH ZERO-P IMPLANT 9MM HEIGHT LORDOTIC-STERILE, ONE 12MM LONG CERVICAL LOCKING SCREW AND THREE 14MM LONG CERVICAL LOCKING SCREWS. X-RAY TAKEN 2 WEEKS POST OPERATIVE, SHOWED NO ISSUES WITH THE IMPLANTS. DURING THE FIRST ROUTINE FOLLOW-UP, X-RAY SHOWED ONE OF THE FOUR SCREWS WAS BACKING OUT. DURING THE SECOND FOLLOW-UP, X-RAY SHOWED A SECOND SCREW WAS BACKING OUT. PT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE HARDWARE. THIS REPORT IS #3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM TI CERVICAL SPINE LOCKING SCREWS TI CERVICAL SPINE LOCKING SCREWS ODP SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ZERO-P IMPLANT