BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNATE IMPLANT 3.6MM X 55MM

    MDR report key: 17760429 · Received September 15, 2023

    Report

    Report Number
    3012835528-2023-00004
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 15, 2023
    Manufacturer
    EXSOMED CORPORATION
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED A SURGEON REACHED OUT BECAUSE DURING THE FOUR-WEEK POST-OPERATIVE X-RAY, THE INNATE IMPLANT 3.6MM X 55MM SCREW (PART NUMBER EXINN923655, BATCH NUMBER 22200-42) WAS BENT. PER INFORMATION RECEIVED, THE PATIENT HAD BEEN NON-COMPLIANT, USING THEIR HAND WITHOUT A SPLIT FOR WEIGHT BEARING DUE TO OTHER INJURIES. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO PAIN AND STILL HAD FULL RANGE OF MOTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780017 INNATE IMPLANT 3.6MM X 55MM SCREW, FIXATION, BONE HWC EXSOMED CORPORATION EXINN923655 22200-42

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other