BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER COMPRESSION SCREW 4.0X44 MM

    MDR report key: 13105907 · Received December 29, 2021

    Report

    Report Number
    3014554088-2021-00004
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 29, 2021
    Manufacturer
    OSSIO LTD.
    Product Code
    HWC
    UDI-DI
    07290017630229
    PMA / PMN Number
    K193360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SURGEON REPORTED A BROKEN DEVICE IN 1ST IPJ FUSION, 3 WEEKS POST-OP, CAUSING A DORSAL WOUND. REMOVAL SURGERY PERFORMED THE NEXT DAY. IMMEDIATE POST-OP IMAGING SHOWED GOOD ALIGNMENT AND STABILITY. IT WAS REPORTED THAT THE PATIENT HAD PRE-EXISTING MEDICAL CONDITIONS AND WAS WEIGHT-BEARING ON DAY 1 POST-OP, CONTRARY TO THE SURGEONS' RECOMMENDATIONS. THE ACTUAL DEVICE COULD NOT BE EXAMINED AS IT WAS NOT PROVIDED TO THE COMPANY. AN INVESTIGATION WAS PERFORMED INCLUDING INTERNAL ANALYSIS OF RECORDS, AND SURGEONS' FEEDBACK. THERE IS NO INDICATION OF A DESIGN, MANUFACTURING OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE INVESTIGATION CONCLUDED THAT THIS EVENT WAS THE OUTCOME OF PATIENT NON-COMPLIANCE WITH POST-OPERATIVE CARE RECOMMENDATIONS RESULTING IN IMPLANT BREAKAGE. THE INSTRUCTIONS FOR USE INCLUDE PRECAUTIONS THAT THE PATIENT IS WARNED THAT THE DEVICE MIGHT BREAK OR BE DAMAGED AS A RESULT OF EARLY WEIGHT BEARING. IT ALSO EMPHASIZES CORRECT PATIENT SELECTION AND CONTRAINDICATES USE IN PATIENTS WHERE POST-OP COMPLIANCE CANNOT BE GUARANTEED. ALTHOUGH THE COMPANY DOES NOT BELIEVE THAT THE DEVICE DIRECTLY CAUSED THE INJURY, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORT FROM THE INITIAL IMPORTER RELATING TO THIS EVENT: #3014323288-2021-00004.

    Description of Event or Problem · 0

    BROKEN OSSIOFIBER COMPRESSION SCREW 4.0X44 MM IN FIRST IPJ FUSION, 3 WEEKS POST-OP, CAUSING A DORSAL WOUND. REMOVAL SURGERY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001397 OSSIOFIBER COMPRESSION SCREW 4.0X44 MM SCREW, FIXATION, BONE HWC OSSIO LTD. OF1024044S OF00331 07290017630229

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention