BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS MINI PLATING SYSTEM

    MDR report key: 1637744 · Received March 19, 2010

    Report

    Report Number
    9710629-2010-00001
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    May 22, 2009
    Report Date
    March 18, 2010
    Manufacturer
    INION OY
    Product Code
    MAI
    PMA / PMN Number
    K023887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS CASE THE CAST HAD BEEN REMOVED TOO EARLY, I.E., ONLY 3 WEEKS POSTOPERATIVELY (VS TYPICAL BONE HEALING TIME OF 6 WEEKS), AND THEREFORE, THE ROOT CAUSE OF THIS INCIDENT IS IMPROPER USE. NOTE THAT THE INSTRUCTIONS FOR USE OF INION OTPS MINI STATES THAT THE DEVICE IS USED IN CONJUNCTION WITH APPROPRIATE IMMOBILIZATION: INDICATIONS: THESE INION OTPS BIODEGRADABLE FIXATION SYSTEM IMPLANTS ARE INTENDED FOR USE IN FIXATION OF NON-COMMINUTED DIAPHYSEAL FRACTURES OF THE METACARPAL, PROXIMAL PHALANGEAL, MIDDLE PHALANGEAL AND OSTEOTOMIES IN THE PRESENCE OF APPROPRIATE IMMOBILIZATION. CONTRAINDICATIONS: THESE INION OTPS BIODEGRADABLE FIXATION SYSTEM IMPLANTS ARE NOT INTENDED FOR USE IN AND ARE CONTRAINDICATED FOR: ACTIVE OR POTENTIAL INFECTION. PATIENT CONDITIONS INCLUDING LIMITED BLOOD SUPPLY, INSUFFICIENT QUANTITY OR QUALITY OF BONE; AND WHERE PATIENT COOPERATION CANNOT BE GUARANTEED (E.G., ALCOHOLISM, DRUG ABUSE). LOAD BEARING PROCEDURES.

    Description of Event or Problem · 1

    ACCORDING TO THE RECEIVED INFORMATION, SURGEON PERFORMED AN OPERATION WITH INION OTPS MINI HAND PLATES USING INION OPTS 2.0 MM SCREWS ON (B) (6) 2009. A CAST WAS APPLIED. THE CAST WAS REMOVED ON (B) (6) 2009. DURING A VISIT ON (B) (6) 2009, IT WAS NOTED THAT THE FIXATION HAD FAILED, AND A REOPERATION WAS DONE WITH METAL IMPLANTS ON (B) (6) 2010. DURING REOPERATION, IT WAS NOTICED THAT THE BIODEGRADABLE PLATE WAS BENT AND THE SCREWS WERE BROKEN. THE PATIENT OUTCOME IS REPORTED GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION OTPS MINI PLATING SYSTEM BONE PLATE, BONE SCREW, BIODEGRADABLE MAI INION OY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention