BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS DISTAL RADIUS PLATE

    MDR report key: 2050735 · Received March 31, 2011

    Report

    Report Number
    9710629-2011-00002
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    November 1, 2007
    Report Date
    March 30, 2011
    Manufacturer
    INION OY
    Product Code
    HRS
    PMA / PMN Number
    K052624
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF PUBLISHED DATA AND OCCURRENCE RATE. ACCORDING TO THE PUBLICATION, 78 DISTAL RADIUS FRACTURES WERE TREATED USING THE INION OTPS DISTAL RADIUS PLATE. ALL FRACTURES HEALED IN 2-3 MONTHS BUT IN 3 CASES DEGRADATION RELATED TISSUE REACTION OCCURRED 20-21 MONTHS POSTOPERATIVELY (4% COMPLICATION RATE). AS MENTIONED IN THE PUBLICATION OF KUKK AND NURMI (FOOT AND ANKLE SURGERY 15: 192-197, 2009), MINOR DEGRADATION RELATED SOFT TISSUE REACTIONS MIGHT RESOLVE EVEN WITHOUT SURGICAL REMOVAL OF THE REMNANTS WHEN THE REMAINING MATERIAL FINALLY COMPLETELY DEGRADES. IN MANY CASES MINOR REACTIONS RESPOND TO TREATMENT WITH NSAIDS AND/OR REMOVAL OF FLUID ACCUMULATION WITH A LARGE SIZE NEEDLE. HOWEVER, IT IS NOT KNOWN WHETHER THE SYMPTOMS WOULD HAVE RESOLVED IN THE ABOVE DESCRIBED 3 CASES WITHOUT SURGICAL INTERVENTION (SURGICAL REMOVAL OF FLUID AND GRANULOMATOUS TISSUE). ALTHOUGH TISSUE REACTION IS A KNOWN RISK (ADVERSE EVENT, ANTICIPATED RISK) WHICH ALWAYS EXISTS WITH ALL BIODEGRADABLE IMPLANTS, THESE REACTIONS TYPICALLY OCCUR FIRST 1-2 YEARS POSTOPERATIVELY AND DO NOT AFFECT BONE HEALING NEGATIVELY OR CAUSE PERMANENT DAMAGE OR IMPAIRMENT. TISSUE REACTIONS ARE POSSIBLE WHEN THE DEVICE DEGRADES, ESPECIALLY WHEN A PLATE IS IMPLANTED UNDER A THIN SOFT TISSUE LAYER. HOWEVER, THE OCCURRENCE RATE HAS BEEN REPORTED TO BE VERY LOW WITH POLYLACTIC ACID BASED IMPLANTS, WHICH IS IN LINE WITH INION'S POST MARKET INFORMATION. THE IFU OF INION OTPS DISTAL RADIUS PLATE STATES UNDER ADVERSE EFFECTS: IMPLANTATION OF FOREIGN MATERIALS CAN RESULT IN AN INFLAMMATORY RESPONSE OR ALLERGIC REACTION. TRANSIENT LOCAL FLUID ACCUMULATION MAY OCCUR IN STERILE CIRCUMSTANCES.

    Description of Event or Problem · 1

    INFORMATION FROM A PUBLISHED STUDY: (CHEN ET ALL 2010: LATE FOREIGN-BODY REACTION AFTER TREATMENT OF DISTAL RADIAL FRACTURES WITH POLY-L-LACTIC ACID BIODEGRADABLE IMPLANTS). DISTAL RADIAL FRACTURE WITH INTRA-ARTICULAR INVOLVEMENT CAUSED BY SLIPPING AND FALLING. TREATED BY OPEN REDUCTION AND INTERNAL FIXATION WITH A BIOABSORBABLE PLATE AND SCREWS. AT TWO YEAR F/U, GRADUALLY ENLARGING MASS ON THE VOLAR SIDE OF THE WRIST, WRIST SORENESS, FINGER TINGLING. SURROUNDING TISSUE WAS ERYTHEMATOUS AND SWOLLEN. THE MASS WAS SOFT, NONMOVABLE, AND ELASTIC IN CHARACTER. DEEP PALPATION EXACERBATED PAIN. THE SURGICAL SITE WAS OPENED, FLUID WAS DRAINED AND SEVERAL FRAGMENTS OF A POLYMERIC REMNANTS REMOVED. THE PT OUTCOME IN LAST F/U WAS GOOD. THERE WAS NO EVIDENCE OF INFECTION OR MALIGNANCY. NEITHER WRIST TENDERNESS NOR FINGER TINGLING WAS NOTED. THE SCREW HOLES HAD FILLED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION OTPS DISTAL RADIUS PLATE BONE PLATE HRS INION OY FRF-1060 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention INION OTPS SCREWS FOR PLATE FIXATION