BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW

    MDR report key: 1864738 · Received October 6, 2010

    Report

    Report Number
    1719045-2010-00291
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 6, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    ODP
    PMA / PMN Number
    K073541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT#: THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PREVIOUS FUSION AT C5-C6 10 YEARS +. ZERO-P IMPLANTED FOR CERVICAL STENOSIS ON (B)(6)2010 FOR 2-LEVEL ACDF AT C3-C4, C4-C5. PLATE AND SCREWS COULD NOT BE IDENTIFIED FROM FUSION AT C5-C6 AND WAS NOT REMOVED. UNABLE TO IMPLANT ALL FOUR SCREWS AT C4-C5. PLATE AT C5-C6 WAS LONG AND HUNG OVER VERTEBRAL BODY AT C5. ORIENTATION OF PLATE AT C5-C6 OBSTRUCTED PLACEMENT OF ONE OF INFERIOR SCREWS. ONE INFERIOR SCREW AND TWO SUPERIOR SCREWS IMPLANTED AT C4-C5. FOUR SCREWS PLACED WITH ZERO-P AT C3-C4. FOLLOW UP X-RAYS (B)(6)2010 SHOWED SUPERIOR SCREW BACKING OUT OF ZERO-P AT C4-C5. ZERO-P AT C3-C4 MIGRATING ANTERIORLY. ZERO-P AND SCREWS AT C3-C4, C4-C5 REMOVED. SECOND OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention ZERO-P IMPLANT