BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1905794 · Received November 19, 2010

    Report

    Report Number
    2520274-2010-00214
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT WITH CERVICAL SPONDYLOSIS, HERNIATED CERVICAL DISK AND POSTERIOR OSTEOPHYTES. PATIENT IMPLANTED WITH 2-LEVEL CLSP PLATE AND SCREWS FOR A 3-LEVEL PROCEDURE AT C4-C5, C5-C6, C6-C7 ON (B)(6) 1996. PATIENT COMPLAINED OF NECK AND ARM PAIN. BROKEN PLATE NOTED BETWEEN C4 AND C5 AND TWO BROKEN SCREWS AT C4 WITH NO REPORTED TRAUMA. PATIENT BROUGHT TO OPERATING ROOM FOR REMOVAL OF BROKEN PLATE AND SCREWS. REMOVAL PSEUDOARTHROSIS AND REMAINING DISC, RIGHT ILIAC CREST AUTOGRAFT HARVEST AND PLACEMENT OF VECTRA T DYNAMIC PLATE AND SCREWS ON (B)(6) 2010. LATERAL AND ANTERIOR X-RAYS AND MRI TAKEN ON AN UNKNOWN DATE. THIS IS THE 2ND OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ILIAC CREST BONE GRAFT| PLATE