BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTUS PHS SYSTEM

    MDR report key: 10497792 · Received September 4, 2020

    Report

    Report Number
    3008480376-2020-00016
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 4, 2020
    Manufacturer
    CONVENTUS ORTHOPAEDICS, INC.
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE SURGEON REMOVED THE PH CAGE. DURING THE SURGERY, THE PROX POSTERIOR SCREW HEAD BROKE OFF BELOW THE CORTEX. THE PROX ANTERIOR DRIVER TIP BROKE OFF FLUSH IN THE COLD-WELDED SCREW. THE MID-LEVEL ANTERIOR SCREW WENT THROUGH THE PLATE BUT WAS ABLE TO BE RETRIEVED. REMOVAL WAS NOT DEEMED NECESSARY AS THE TIPS WERE FLUSH WITH THE SCREW HEAD(S). CONVENTUS ORTHOPAEDICS, INC. IS SUBMITTING THREE SEPARATE MDRS FOR EACH OF THESE THREE BREAKAGE EVENTS. THIS MDR IS REGARDING THE MID-LEVEL ANTERIOR SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956969 CONVENTUS PHS SYSTEM NAIL, FIXATION, BONE JDS CONVENTUS ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other