BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CANCELLOUS BONE SCREWSLF-TPNGNARIABLE A

    MDR report key: 2211383 · Received August 9, 2011

    Report

    Report Number
    2520274-2011-00540
    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

    WITHOUT THE PLATE AND SCREWS RETURNED IT CANNOT BE DETERMINED IF ANY HARDWARE NON-CONFORMANCES LED TO THIS EVENT. BASED ON THE X-RAYS THE ANGULATION OF THE SCREW COULD HAVE CONTRIBUTED TO THE BACKOUT, BUT IT CANNOT BE DETERMINED IF THIS OCCURRED DURING INSERTION, OR AFTER SOME SETTLING/ANATOMICAL CONSTRUCT MOTION. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    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 SIX OF SEVEN REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    FIRST ACDF PROCEDURE WAS PERFORMED AT LEVEL, C5-6, C6-7. SURGEON REPORTED THERE WAS A NON-UNION AT C6-7 AND PATIENT WAS REVISED TO FUSION AT LEVELS C3-4, C4-5, AND C6-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM TI CANCELLOUS BONE SCREWSLF-TPNGNARIABLE A CANCELLOUS BONE SCREWSLF-TPNG HWC SYNTHES MONUMENT

    Patients

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