BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI ANTERIOR CERVICAL COMPRESSION PL 2 LEVEL/37MM

    MDR report key: 2211444 · Received August 9, 2011

    Report

    Report Number
    2520274-2011-00535
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K033844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. W/O A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST ACDF C4-5, C5-6 IMPLANTATION ON AN UNK DATE HAD AN X-RAY ON AN UNK DATE THAT SHOWED A NON-UNION AND ADJACENT LEVEL DISEASE. THE PLATE AND SIX SCREWS WERE INTACT AND NOT BROKEN. DURING THE PROCESS OF REMOVAL OF THE PLATE AND SCREWS, A PIECE OF THE EXTRACTION SCREWDRIVER BROKE OFF. SURGEON VACUUMED UP THE PART AND COMPLETED REMOVING THE PLATE AND SCREWS W/O INCIDENT. PT WAS REVISED TO TWO PLATES AND SCREWS. THIS IS ONE OF SEVEN REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI ANTERIOR CERVICAL COMPRESSION PL 2 LEVEL/37MM ANTERIOR CERVICAL COMPRESSION PL HWC SYNTHES MONUMENT 1326658

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male SCREW| SCREW