BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 7756858 · Received August 7, 2018

    Report

    Report Number
    2939274-2018-53214
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    July 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID AND WEIGHT WERE NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. IMPLANTED, EXPLANTED DATES: UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CURTIN C., CHUNG K. (2002), USE OF EIGHT-HOLE TITANIUM MINIPLATES FOR UNSTABLE PHALANGEAL FRACTURES. ANNALS OF PLASTIC SURGERY. VOLUME 49, NUMBER 6, PAGES 580-586 (USA). THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO DESCRIBE THE EXPERIENCES AFTER FIXATION USING AN EIGHT-HOLE MINIPLATE SYSTEM AS TREATMENT FOR UNSTABLE PHALANGEAL FRACTURES. FROM MAY 2000 TO AUGUST 2001, 13 PATIENTS (16 PHALANGEAL FRACTURES) WITH AGE RANGING FROM 15 ¿ 66 YEARS WERE REVIEWED FOR THIS STUDY. THESE PATIENTS WERE FIXED WITH AN UNKNOWN SYNTHES EIGHT-HOLE LOW-PROFILE TITANIUM PLATING SYSTEM, USING EITHER 1.0 MM OR 1.5 MM SCREWS. FUNCTIONAL OUTCOME IN THE DIGITS RESULTS WERE CATEGORIZED BY; EXCELLENT (FINGERS 220-260, AND THUMB 119-140), GOOD (FINGERS 180-219, AND THUMB 98-119), FAIR (FINGERS 130-179, AND THUMB 70-97), AND POOR (FINGERS <130, AND THUMB <70). CLINICAL FOLLOW-UPS WERE DONE 1 WEEK POST-OP AND X-RAYS WERE CHECKED EVERY 3 WEEKS UNTIL FRACTURE HEALING IS ACHIEVED. COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR OLD MALE PATIENT HAD EXTENSOR LAG; EXTENSOR TENOLYSIS AND PLATE REMOVAL. THIS REPORT IS FOR ONE (1) UNKNOWN EIGHT-HOLE LOW-PROFILE TITANIUM PLATE. THIS REPORT IS 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601029 PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention