BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALLUX OSTEOTOMY PLATE

    MDR report key: 6669551 · Received June 27, 2017

    Report

    Report Number
    3004369035-2017-00002
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    May 26, 2017
    Report Date
    June 27, 2017
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120047298664
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO LACK OF INFORMATION OF THE INCIDENT AND THE PRODUCT ITSELF, THE LAST QUALITY INSPECTION DOCUMENTS, INCLUDING THE MATERIAL CERTIFICATES OF THE HALLUX OSTEOTOMY PLATE AND THE LOCKING SCREW WERE CHECKED AND NO DEVIATION WAS FOUND. WE HAVE SEND A REQUEST TO THE DISTRIBUTION PARTNER TO GAIN MORE INFORMATION OF THE INCIDENT. WE HAVE NOT RECEIVED THE PRODUCT BACK.

    Description of Event or Problem · 1

    CONCERNING THE COMPLAINT FORM WE HAVE RECEIVED FROM OUR DISTRIBUTOR, A D=3.0MM CANCELLOUS SCREW HAS NOT LOCKED IN A HALLUX OSTEOTOMY PLATE. DUE TO THIS ANOTHER SCREW WAS USED TO FINISH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452474 HALLUX OSTEOTOMY PLATE HOL HRS I.T.S. GMBH 21015-08 09120047298664

    Patients

    Seq Age Sex Outcome Treatment
    1 Other