BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIPLATE CERVICAL 18MM PLATE

    MDR report key: 2092616 · Received May 9, 2011

    Report

    Report Number
    1526439-2011-00074
    Event Type
    Injury
    Date Received
    May 9, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K042544
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATE AND SCREW ARE TITANIUM AND WHILE IT IS UNLIKELY THAT THE ISSUE IS RELATED TO METAL SENSITIVITY, THERE IS THE REMOTE POSSIBILITY THAT THIS IS THE CAUSE OF THE ISSUE. THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICES LISTS FOREIGN BODY SENSITIVITY AS A POSSIBLE ADVERSE OUTCOME. NO CONNECTION CAN BE MADE AT THIS TIME BETWEEN THE POST-OP ISSUE AND THE USE OF THE DEPUY PRODUCTS.

    Description of Event or Problem · 1

    ALLERGIST CONTACTED DEPUY SPINE TO GATHER TEST SAMPLE OF PRODUCT PLACED IN PATIENTS CERVICAL SPINE. THE PATIENT WAS IMPLANTED WITH CERVICAL HARDWARE IN (B)(6) 2010. THREE MONTHS AFTER SURGERY, PATIENT DEVELOPED A SIGNIFICANT ITCH. TESTING HAS FOUND NO CAUSE FOR THE ITCH TO DATE. ALLERGIST DOES NOT BELIEVE THE PROBLEM IS RELATED TO THE SPINAL IMPLANTS BUT WANTS TO RULE IT OUT. HE REPORTED THAT THERE IS NO SWELLING OR RASH AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIPLATE CERVICAL 18MM PLATE CERVICAL FIXATION DEVICE KWQ DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention UNIPLATE SCREW: (B)(4)| BENGAL CAGE: (B)(4)