BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORIAN® SRS® BONE VOID FILLER ROTARY MIX 3CC-STERILE

    MDR report key: 2666713 · Received July 18, 2012

    Report

    Report Number
    2520274-2012-01275
    Event Type
    Injury
    Date Received
    July 18, 2012
    Report Date
    June 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    PMA / PMN Number
    PK060408
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: GXP. (B)(4). DEVICE NOT REPORTED AS EXPLANTED. MANUFACTURE BY: SUPPLIER (B)(4), PACKAGED BY: (B)(4). MANUFACTURING DATE: JULY 02, 2009. EXPIRATION DATE: MARCH 31, 2011. ONE NON-CONFORMANCE REPORT WAS ISSUED FOR LABEL DAMAGED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. DEVICE WAS 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

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PT WHO WAS TREATED WITH NORIAN CRS, ON AN UNK DATE, HAS DEVELOPED REDNESS AROUND THE EAR AREA. SURGEON PERFORMED AN ALLERGY TEST. SURGEON HAS REQUESTED THE MATERIAL COMPOSITION OF NORIAN CRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORIAN® SRS® BONE VOID FILLER ROTARY MIX 3CC-STERILE FILLER, CALCIUM SULFATE PREFOR MED PELLETS MQV SYNTHES MONUMENT N996967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention