BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALLUX OSTEOTOMY PLATE, 8MM

    MDR report key: 13364790 · Received January 27, 2022

    Report

    Report Number
    3004369035-2022-00001
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    December 23, 2021
    Report Date
    January 27, 2022
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120047298664
    PMA / PMN Number
    K131722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE (DHR) SHOWS THIS LOT OF THE HALLUX OSTEOTOMY PLATE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCE. WE HAVE CONSULTED AN EXPERIENCED TRAUMA SURGEON FOR HIS INDEPENENT OPINION: THE X-RAYS SHOW A GAP IN THE AREA OF THE OSTEOTOMY, WHICH CAN CONTRIBUTE TO DELAYED BONE HEALING. APPARENTLY, THE PERIOSTEAL TISSUE WAS EXTENSIVELY DAMAGED IN THE COURSE OF THE OSTEOTOMY, AS IT IS UNTYPICAL THAT THERE ARE STILL NO SIGNS OF BONE HEALING AFTER 1-1,5 MONTHS. IT IS SUSPECTED, THAT A TOO SMALL IMPLANT SIZE WAS CHOSEN, THUS LED TO IMPROPER ANCHORING OF THE BARBS IN THE INTRAMEDULLARY CANAL AND SUBSEQUENT CAUSED THE SCREW PASSING THROUGH THE PLATE HOLE. THIS IS REPORT 1 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOCKING SCREW PASSED THE PLATE HOLE APPROX. 1-1,5 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798788 HALLUX OSTEOTOMY PLATE, 8MM HALLUX OSTEOTOMY PLATE, 8MM HRS I.T.S. GMBH 21015-08 00/0720-01 09120047298664

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention