BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN DRILLABLE INJECT 10CC-STERILE

    MDR report key: 5081345 · Received September 16, 2015

    Report

    Report Number
    1719045-2015-10597
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Report Date
    August 30, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    PMA / PMN Number
    PK102722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT IMPLANTED AS PRODUCT STIFFENED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ P/N:07.704.110S LOT: DSC2469 RELEASED: (B)(6) 2014 EXP: 4/28/16. DSM BIOMEDICAL MANUFACTURED THE NORIAN DRILLABLE FAST SET PUTTY 10CC - STERILE, P/N 07.704.010S, AND LOT NUMBER DSC2469. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE INDICATES THAT THE PARTS WERE MANUFACTURED AND MET ALL THE REQUIRED SPECIFICATIONS. THE PATS WERE INSPECTED AND CONFORMED TO SYNTHES INCOMING FINAL INSPECTION SHEET. NO NCRS WERE GENERATED FOR THIS LOT AND THE PARTS WERE RELEASED (B)(6) 2014. 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

    IT WAS REPORTED THAT DURING SURGERY THE END OF A PLASTIC PIECE OF TUBE (WHICH IS CONNECTED TO THE INNER POUCH TO RECEIVE THE PASTE AFTER MIXING) BROKE. ANOTHER 10 CC NORIAN DRILLABLE ROTARY POUCH COMPONENT WAS USED TO COMPLETE THE SURGERY. NO PATIENT HARM AND NO DELAY IN SURGERY WAS REPORTED. NO PATIENT INFORMATION AVAILABLE. IT WAS ORIGINAL SURGERY. THE SOLUTION BECOME HARD EVENTUALLY SINCE THE END OF THE TUBE WAS BROKEN. THE COMPLAINED DEVICE WAS DISCARDED. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613650 NORIAN DRILLABLE INJECT 10CC-STERILE FILLER, CALCIUM SULFATE PREFOR MED PELLETS MQV SYNTHES MONUMENT DSC2469

    Patients

    Seq Age Sex Outcome Treatment
    1