BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRS FAST SET PUTTY 10CC BONE CEMENT-STERILE

    MDR report key: 3072668 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-01229
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    PMA / PMN Number
    K060406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(4) MANUFACTURED THE CRS FAST SET PUTTY 15CC - STERILE, PART 613.15.01S, AND LOT NUMBER N652600. THE LOT CONFORMED TO NORIAN WORK ORDER (B)(4), CLOSED APRIL 21, 2005, AND SYNTHES PURCHASE ORDER (B)(4), RELEASED JUNE 7, 2005. THERE WERE NO NON CONFORMITIES, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. NEW INFORMATION WAS RECEIVED FROM RETURNED HOSPITAL QUESTIONNAIRE. PLACEHOLDER.

    Description of Event or Problem · 1

    SURGEON REPORTED TO PRODUCT DEVELOPMENT THAT HE IS NOTICING VARIOUS ISSUES WITH PATIENTS IMPLANTED WITH NORIAN PUTTY. IN SOME CASES, THE PUTTY HAS CRUMBLED TOWARD THE CENTER. IN OTHER CASES THE PUTTY APPEARED TO BUBBLE UP AND BECOME ROUGH. SURGEON ALSO REPORTED SOME PATIENTS DEVELOPED AN INFECTION. IN ALL CASES, SURGEON REPORTS HE REMOVED THE PRODUCT FROM THE PATIENT. A (B)(6) PATIENT WITH MULTIPLE SKULL LESIONS IMPLANTED WITH NORIAN ON (B)(6) 2005 AND DEVICE WAS REMOVED ON (B)(6) 2010. POST-OPERATIVE IMMOBILITY, RESTRICTIONS PRESCRIBED WERE: NO BENDING, TWISTING AND LIFTING OVER 20 POUNDS. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173815 CRS FAST SET PUTTY 10CC BONE CEMENT-STERILE MQV SYNTHES MONUMENT N652600

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention