BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN REINFORCED FAST SET PUTTY/3CC

    MDR report key: 4781078 · Received May 19, 2015

    Report

    Report Number
    3000270450-2015-10104
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Report Date
    April 29, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    GXP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THE ACTUAL EVENT DATE IS UNKNOWN. IT WAS ORIGINALLY REPORTED AS BEING (B)(6) 2015, BUT THE PROCEDURE REFERENCED IN THE COMPLAINT DID NOT OCCUR UNTIL (B)(6) 2015. (B)(4). NO 510K INFORMATION IS AVAILABLE FOR THIS PRODUCT AT THIS TIME AS IT IS NOT CURRENTLY DISTRIBUTED IN THE UNITED STATES. A PREVIOUSLY ASSOCIATED 510K NUMBER WAS K102018. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING SITE: (B)(4) - MANUFACTURING DATE: NOVEMBER 11, 2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY ON (B)(6) 2015. THE SURGEON NOTED THAT THE 3CC NORIAN REINFORCED PUTTY HAS A LONGER SET TIME THAN THE 10CC. ALSO, THE SURGEON MENTIONED THAT THE STRENGTH, INTENSITY, AND TOUCH OF THE 3CC IS VERY DIFFERENT THAN THAT OF THE 10CC. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324516 NORIAN REINFORCED FAST SET PUTTY/3CC METHYL METHACRYLATE FOR CRANIPLASTY GXP SYNTHES SELZACH DSC2473

    Patients

    Seq Age Sex Outcome Treatment
    1