BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-ALIF

    MDR report key: 18155303 · Received November 16, 2023

    Report

    Report Number
    3009962553-2023-00004
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 16, 2023
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    UDI-DI
    03700780627127
    PMA / PMN Number
    K172083
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    3 SCREWS WERE USED NORMALLY WITHOUT PROBLEM. THE SURGEON WAS UNABLE TO PROPERLY LOCK THE FOURTH SCREW INTO THE PLATE. THE SURGEON OPTED TO NOT SWAP OUT THE PLATE AND JUST USED 3 SCREWS. ACCORDINGLY, THIS EVENT IS REPORTABLE AS A MALFUNCTION. (B)(6) 2024 - THE PLATE USED WAS CONFORMING TO CLARIANCE'S SPECIFICATION (CONTROL REPORT AND RAW MATERIAL CERTIFICATES). ANALYSIS ON THE PARTS WAS NOT POSSIBLE, AS IT WAS NOT EXPLANTED FROM THE PATIENT. CLARIANCE'S TEAM WAS ABLE TO REPRODUCE THE EVENT WHERE THE SLEEVE WAS NOT FIRMLY TIGHTENED WHILE THE SCREW WAS FULLY INSERTED. SAME DIFFICULTY WITH THE SCREW REMOVAL WAS OBSERVED. HOWEVER, WITH THE USE OF THE PROVIDED COUNTER TORQUE, AND T20 TIGHTENING KEY, UNTIGHTENING OF THE SCREW WAS MADE POSSIBLE WITHOUT ISSUE. TWO HYPOTHESES WERE MADE, ONE REGARDING THE CONDITION IN WHICH THE SURGEON TRIED TO REMOVE THE DEVICE, WITH LACK OF VISIBILITY AND PRESENCE OF TISSUES CONFLICTING WITH THE USE OF THE COUNTER TORQUE, AND ONE WITH THE METHOD USED.

    Additional Manufacturer Narrative · 0

    3 SCREWS WERE USED NORMALLY WITHOUT PROBLEM. THE SURGEON WAS UNABLE TO PROPERLY LOCK THE FOURTH SCREW INTO THE PLATE. THE SURGEON OPTED TO NOT SWAP OUT THE PLATE AND JUST USED 3 SCREWS. ACCORDINGLY, THIS EVENT IS REPORTABLE AS A MALFUNCTION.

    Description of Event or Problem · 0

    SURGEON COULDN'T GET SCREW TO LOCK INTO PLATE DURING IMPLANTATION. UPON INSPECTION, THE LOCKING RING LOOKED FINE AND NOT DAMAGED AT ALL TO SURGEON. THE SURGEON OPTED TO NOT SWAP OUT THE PLATE AND JUST USE THREE SCREWS. HE CLEARED THE PLATE/SCREW INTERFACE AREA OF ANY DEBRIS AND THE SCREW STILL WOULDN'T LOCK. AT THIS POINT, IT WAS ADJUDGED BY THE SURGEON TO PROCEED WITH THREE SCREWS.

    Description of Event or Problem · 0

    SURGEON COULDN'T GET SCREW TO LOCK INTO PLATE DURING IMPLANTATION. UPON INSPECTION, THE LOCKING RING LOOKED FINE AND NOT DAMAGED AT ALL TO SURGEON. THE SURGEON OPTED TO NOT SWAP OUT THE PLATE AND JUST USE THREE SCREWS. HE CLEARED THE PLATE/SCREW INTERFACE AREA OF ANY DEBRIS AND THE SCREW STILL WOULDN'T LOCK. AT THIS POINT, IT WAS ADJUDGED BY THE SURGEON TO PROCEED WITH THREE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293415 IDYS-ALIF IDYS-ALIF PLATE H14MM OVD CLARIANCE SAS 24430014-S N339X-N317Y 03700780627127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown