BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, CALCIUM SULFATE PREFORMED PELLETS

    MDR report key: 4268912 · Received November 21, 2014

    Report

    Report Number
    1719045-2014-10616
    Event Type
    Injury
    Date Received
    November 21, 2014
    Report Date
    October 29, 2014
    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

    DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: (B)(4) MANUFACTURED THE SRS BONE VOID FILLER ROTARY MIX 10CC - STERILE, P/N SRS-010-RMS, AND LOT #N000828 FOR PO #1271675. THE LOT CONFORMED TO (B)(4) (CLOSED MAY 9, 2011) AND SYNTHES PURCHASE ORDER (B)(4)(RELEASED JUNE 3, 2011). THERE WERE NO MRR¿S OR NCR¿S GENERATED FOR THIS LOT. BRAND NAME: NORIAN SRS-010-RMS 10CC BONE VOID FILLER. 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

    COMPLAINT HANDLING UNIT RECEIVED A MAUDE REPORT FORWARDED FROM J&J LEGAL DEPARTMENT FOR MEDWATCH #(B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE MAUDE EVENT REPORT IS ATTACHED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755838 FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV SYNTHES MONUMENT N000828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R