BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3746552 · Received April 11, 2014

    Report

    Report Number
    0009617544-2014-00152
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW RESULTS: THE CUSTOMER REPORTED AN ALLERGIC REACTION TO AN UNKNOWN STRYKER SPINE SCREW PRODUCT WHICH WAS IMPLANTED IN THE CUSTOMER. THE SCREW PRODUCTS COULD NOT BE IDENTIFIED, THEREFORE FURTHER EVALUATION IS IMPOSSIBLE AT THIS MOMENT. CONCLUSION: THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED DUE TO THE ABSENCE OF THE DEVICE AND LIMITED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD SPINAL SURGERY IN (B)(6) 2013 WHICH REQUIRED A SINGLE LEVEL FUSION AS WELL AS 2 SCREWS FROM STRYKER SPINE (ACCORDING TO THE SURGEON). SINCE THE SURGERY, THE PATIENT BROKE OUT IN HIVES ON A DAILY BASIS. THE SURGEON ADVISED THE PATIENT TO WAIT FOR 3 MONTHS AS MOST OF THE MATERIALS USED WOULD NATURALLY ABSORB OR DISSOLVE. HOWEVER IT HAS BEEN ALMOST 5 MONTHS WITH NO IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD SPINAL SURGERY IN (B)(6) 2013 WHICH REQUIRED A SINGLE LEVEL FUSION AS WELL AS 2 SCREWS FROM STRYKER SPINE (ACCORDING TO THE SURGEON). SINCE THE SURGERY, THE PATIENT BROKE OUT IN HIVES ON A DAILY BASIS. THE SURGEON ADVISED THE PATIENT TO WAIT FOR 3 MONTHS AS MOST OF THE MATERIALS USED WOULD NATURALLY ABSORB OR DISSOLVE. HOWEVER IT HAS BEEN ALMOST 5 MONTHS WITH NO IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220373 UNKNOWN_SPINE_PRODUCT UNK NKB STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization