BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM

    MDR report key: 11956677 · Received June 8, 2021

    Report

    Report Number
    3003407235-2021-00002
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    January 1, 2005
    Report Date
    June 8, 2021
    Manufacturer
    INION OY
    Product Code
    JEY
    PMA / PMN Number
    K010352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLICATION RATE OF INION CPS IMPLANTS EQUALED (B)(4) COMPARED WITH A COMPLICATION RATE OF (B)(4) IN THE TITANIUM PLATE RIGID FIXATION COMPARISON POPULATION. THE AUTHORS CONCLUDE THAT MANDIBLE FRACTURES TREATED WITH RESORBABLE FIXATION IN THIS STUDY DEMONSTRATED A COMPLICATION RATE HIGHER THAN THAT OF TITANIUM FIXATION GROUP, ALTHOUGH THIS WAS NOT STATISTICALLY SIGNIFICANT. THE PATTERN OF ANGLE FRACTURE RESULTING IN THE HIGHEST COMPLICATION RATE WAS ONCE AGAIN DEMONSTRATED IN THIS STUDY; HOWEVER, ALL COMPLICATIONS WERE MANAGED ACCORDINGLY AND RESULTED IN A SATISFACTORY OUTCOME IN ALL CASES.

    Description of Event or Problem · 1

    INFORMATION FROM A POSTER BY GIBSON 2007 - USA - COMPARING 2.5 MM RESORBABLE PLATES AND SCREWS TO 2.0 MM TITANIUM PLATES AND MONOCORTICAL SCREWS IN THE TREATMENT OF MANDIBLE FRACTURES. IN ALL CASES BONY UNION WAS EVIDENT. A TOTAL OF 6 COMPLICATIONS OCCURRED WITH INION CPS DEVICES: 1 DEFINED AS INFECTION AND/OR NON-UNION REQUIRING DEBRIDEMENT AND REAPPLICATION OF A TITANIUM PLATE AND 5 DEFINED AS LOCALIZED HARDWARE INFECTION OR EXPOSURE OF HARDWARE REQUIRING HARDWARE REMOVAL ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853662 INION CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM PLATE, BONE ; BONE SCREW JEY INION OY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention