BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS MINI SCREW

    MDR report key: 1273817 · Received December 23, 2008

    Report

    Report Number
    9710629-2008-00003
    Event Type
    Injury
    Date Received
    December 23, 2008
    Date of Event
    August 28, 2008
    Report Date
    December 5, 2008
    Manufacturer
    INION OY
    Product Code
    HWC
    PMA / PMN Number
    K043142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE FINAL RELEASE RESULTS OF THE SAME LOT. WITHOUT ADD'L INFO, IT IS IMPOSSIBLE TO KNOW WHAT EXACTLY HAD HAPPED. HOWEVER, AS THE FINAL RELEASE RESULTS OF THE PRODUCTION LOT WERE OK THE FIXATION FAILURE MUST HAVE BEEN CAUSED BY SOME FORCE EXCEEDING THE MECHANICAL STRENGTH OF THE SCREWS. CONSIDERING THE TYPE OF THE FRACTURE, AND AGE AND GENDER (FEMALE) OF THE PT OSTEOPOROSIS (INSUFFICIENT BONE QUALITY) MAY HAVE CONTRIBUTED TO THIS COMPLICATION. LARGER DIAMETER SCREWS OR METAL IMPLANTS MIGHT HAVE PROVIDED BETTER FRACTURE STABILITY. PLEASE SEE THE FOLLOWING STATEMENTS IN THE IFU: THESE INION OTPS BIODEGRADABLE FIXATION SYSTEM IMPLANTS ARE NOT INTENDED FOR USE IN AND ARE CONTRAINDICATED FOR: PT CONDITIONS INCLUDING LIMITED BLOOD SUPPLY, INSUFFICIENT QUANTITY OR QUALITY OF BONE; AND WHERE PT COOPERATION CANNOT BE GUARANTEED (E.G. ALCOHOLISM, DRUG ABUSE). HIGH-LOAD BEARING APPLICATIONS UNDER THE ABOVE MENTIONED INDICATION CATEGORIES A AND B. OTHERWISE, LOAD BEARING INDICATIONS (E.G. DIAPHYSEAL FRACTURES OF LONG BONES) UNLESS USED IN CONJUNCTION WITH TRADITIONAL RIGID FIXATION. GOOD ALIGNMENT/REDUCTION OF THE FRACTURE/OSTEOTOMY.

    Description of Event or Problem · 1

    ACCORDING TO THE RECEIVED INFO, A LADY WITH ELBOW RADIUS NECK FRACTURE WAS TREATED WITH TWO INION OTPS MINI 2.5MM X 23 SCREWS. THREE WEEKS POST-OPERATIVELY, IT WAS NOTICED THAT ONE SCREW WAS BROKEN AND THE OTHER SCREW WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION OTPS MINI SCREW HWC INION OY FRF-1253 0708002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention