BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN REINFORCED FASTSETPUTTY BONEVOIDF

    MDR report key: 5945975 · Received September 13, 2016

    Report

    Report Number
    3000270450-2016-10219
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    August 15, 2016
    Report Date
    August 23, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA NOT EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE 510K#UNKNOWN. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: WRONG PART NUMBER WAS INDICATED, THIS IS THE CORRECT PART NUMBER: CRS-0300-FRP AS INDICATED ON THE COMPLAINT LEVEL. MANUFACTURING SITE: (B)(4) SUPPLIER: (B)(4), MANUFACTURING DATE: 11. NOV. 2014, EXPIRY DATE: 01. MAY 2016, THE SUPPLIER DID CONFIRM THAT THE REVIEW OF THE LABEL RECONCILIATION FORMS CONTAINED WITHIN THE PRODUCT DEVICE HISTORY RECORDS FOR LOT C2473 INDICATE THAT AN EXPIRY DATE WAS PRINTED IN THE APPROPRIATE LOCATION WITHIN THE REQUIRED LABELS, THE TEXT WAS LEGIBLE, AND THE DATE APPLIED WAS CORRECT PER PRODUCT SPECIFICATIONS. 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    DEVICE REPORT FROM SYNTHES ON AN EVENT IN COUNTRY AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THEY USED AN OUT OF DATE NORIAN, THIS WAS NOTICED DURING THIS CASE AND THEY HAD NO OTHER OPTION AT THE TIME BUT TO USE IT. THIS PRODUCT EXPIRED IN MAY 2016, HOWEVER, IT WAS STILL USED IN THE PROCEDURE ON (B)(6) 2016 AS THEY HAD NO OTHER PRODUCT OR CHOICE, IN THIS CASE, THIS WAS THE SURGEONS DECISION TO DO SO. THE SURGEON DECIDED TO USE IT AND THE HOSPITAL ARE TRYING TO DECIDE IF THEY ARE TO TELL THE PATIENT. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598218 NORIAN REINFORCED FASTSETPUTTY BONEVOIDF POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT LOD SYNTHES SELZACH DSC2473

    Patients

    Seq Age Sex Outcome Treatment
    1