BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2121353 · Received June 6, 2011

    Report

    Report Number
    2520274-2011-00185
    Event Type
    Injury
    Date Received
    June 6, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED. UNABLE TO PROVIDE THE MANUFACTURER, PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    CLINICAL COMPLIANCE MANAGER REPORTED: CLINICAL STUDY PT WAS RANDOMIZED TO ACDF IMPLANTATION LEVEL C6-7 ON (B)(6)-2004 RETURNED TO THE SURGEON ON (B)(6)-2009 COMPLAINING OF POSTERIOR CERVICAL PAIN RADIATING INTO HER TRAPEZIUS, DELTOID AND BICEPS. A CT SCAN SHOWED EVIDENCE OF A NON-HEALED FUSION AT C6-7 LEVEL AND EVIDENCE OF A RIGHT SIDED DISK HERNIATION AT C5-6 LEVEL. SURGEON RECOMMENDED REVISION OF THE ACDF WITH A PLATE FROM C5-7, AND A POSTERIOR CERVICAL FUSION FROM C5-7. SITE COORDINATOR NOTED SUBJECT PT HAS MOVED TO SOUTH DAKOTA. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI PLATE KWP SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW