BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 4581277 · Received March 4, 2015

    Report

    Report Number
    2032593-2015-00009
    Event Type
    Other
    Date Received
    March 4, 2015
    Report Date
    February 10, 2015
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED SINCE IT REMAINS IMPLANTED. BASED ON REPORTED INFO, INTEGRA HAS INITIATED AN INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT HAD AN ALLERGIC REACTION AND THE CUSTOMER IS UNAWARE IF THE INTEGRA PRODUCT IS THE SOURCE. THE PHYSICIAN NEEDED TO KNOW IF 2-HYDROXYETHYLMETHACRYLATE IS USED WITH THE CORAL II SYSTEM. THE PHYSICIAN WAS INFORMED BY INTEGRA STAFF THAT THE POLYMER OF CONCERN IS NOT FOUND IN INTEGRA METALLIC PRODUCTS. A PHYSICIAN OFFICE VISIT RECORD WAS FAXED TO INTEGRA. THE DEVICE REMAINS IMPLANTED. SUMMARY OF OFFICE VISIT RECORD FROM DATE OF SERVICE (B)(4) 2015: THE PT PRESENTED TO THE OFFICE FOR A CONSULTATION ON REFERRAL FROM ANOTHER PHYSICIAN. FOUR YEARS AGO, THE PT HAD SURGERY DONE TO HIS LOW BACK WHICH STABILIZED THE LUMBOSACRAL SPINE AT THE L5-S1 INTERFACE. IN THE COURSE OF TIME, THE PT HAS DEVELOPED DERMATOLOGIC PROBLEMS THAT HAVE BEEN GOING ON NOW FOR MANY MONTHS. HE HAS DEVELOPED A PYOGENIC GRANULOMATOUS LESION SCATTERED OVER HIS BODY ALONG WITH WHAT APPEARS TO BE A CONTACT DERMATITIS. HE HAS BEEN TESTED BY THE ALLERGIST WITH SKIN TESTS. THE ONLY THING HE REACTED TO WAS 2 HYDROXYETHYL-METHACRYLATE. THE NURSE PRACTITIONER EVALUATING THE PT PLACED A PHONE CALL TO THE MFR OF THE PROSTHETICS TO DETERMINE WHETHER OR NOT THE IDENTIFIER MATERIAL WAS ON THE PROSTHESIS IMPLANTED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149471 NONE KWP SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other