BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 1269302 · Received December 22, 2008

    Report

    Report Number
    9617544-2008-00247
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 18, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. RESULT, AND CONCLUSION: WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT CALLED SWEDISH CUSTOMER SERVICE TO REPORT THAT A PIECE OF A SPINE SCREW, MANUFACTURED BY STRYKER, HAD BEEN LEFT IN HER SPINE AFTER EXTRACTION SURGERY. STRYKER SALES REP MARIA DALOS CONTACTED THE SURGEON. ACCORDING TO THE SURGEON, THE TIP OF A XIA SCREW HAD BEEN LEFT IN THE PATIENT. THE SURGEON CLAIMS THAT THE PATIENT IS HEALED AND THAT THE REMAINING SCREW PART WILL NOT CAUSE ANY PROBLEMS TO THE PATIENT. THE ITEM NUMBER ON THE SCREW IS UNKNOWN. ACCORDING TO THE SURGEON, THE PATIENT INSISTED ON BRINGING THE SCREWS HOME. THEY ARE THEREFORE NOT AVAILABLE FOR STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT IMPLANT KWQ STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention