BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIABLE TI SCREW AND LOCK SCREW- 3.5MM X 18MM

    MDR report key: 3254143 · Received July 24, 2013

    Report

    Report Number
    9615741-2013-00029
    Event Type
    Other
    Date Received
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    PMA / PMN Number
    K073375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING AN AUDIT AT AINTREE HOSPITAL ((B)(6)), THE TERRITORY SALES MANAGER FOUND A LOT OF CONSIGNMENT STOCK THAT WAS OUT OF DATE AND CHECKED RECENT OPERATIONS. FOR AN ANKLE FUSION SURGERY PERFORMED ON (B)(6) 2013, A SCREW WAS USED THAT HAD AN EXPIRATION DATE OF (B)(6) 2013. ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL WITH A POSSIBLE INFECTION." ADD'L INFO HAS BEEN REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346316 VARIABLE TI SCREW AND LOCK SCREW- 3.5MM X 18MM NA HWC NEWDEAL S.A. EA92

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention