BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIUS LOCKING CAPS

    MDR report key: 2471900 · Received February 27, 2012

    Report

    Report Number
    9617544-2012-00058
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 31, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K062270
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT RETURNED WITH THIS COMPLAINT: CAT #486611550 RADIUS SCREW MULTI-A 5.75 X 50MM. CAT # 486611750 RADIUS SCREW MULTI-A 7.75 X 50MM. CAT #486615035 RADIUS 5.5 X 35 RAD ROD. CAT #486615040 RADIUS 5.5 X 40 RAD ROD. ADDITIONAL INFO HAS BEEN REQUESTED, AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DID A 1 LEVEL LUMBAR USING RADIUS IN (B)(6) 2011. PT WAS COMPLAINING ABOUT PAIN SO SURGEON DID A FOLLOW-UP SCAN. RESULTS OF SCAN INDICATED ROD ON PT'S RIGHT SIDE DISLOCATED FROM SCREW HEAD. DR. (B)(6) DID A REVISION SURGERY IN (B)(6) 2012 AND FOUND THAT ROD ON PT'S RIGHT SIDE WAS DISLODGED FROM SCREW HEADS. HE ALSO FOUND THAT TULIP HEADS OF SCREWS ON PT'S LEFT SIDE WERE LOOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIUS LOCKING CAPS IMPLANT NKB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R