BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 9412186 · Received December 4, 2019

    Report

    Report Number
    2939274-2019-62483
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    March 13, 2009
    Report Date
    November 12, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PLATE/ SCREWS/ UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. (B)(4). 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: ADHAM, M., POREMBSKI, M., AND ADHAM, C. (2009), FLEXOR TENDON PROBLEMS AFTER VOLAR PLATE FIXATION OF DISTAL RADIUS FRACTURES, HAND, VOL. 4, PAGES 406-409, (USA). THIS CASE REPORT PRESENTED AN (B)(6) YEAR-OLD WOMAN WITH PAIN IN THE RIGHT WRIST, STIFFNESS OF THE INDEX AND LONG FINGERS AND PARESTHESIAS IN THE MEDIAN NERVE DISTRIBUTION. SHE HAD UNDERGONE ORIF OF A COMMINUTED INTRA ARTICULAR FRACTURE OF THE RIGHT DISTAL RADIUS WITH BONE GRAFTING AND A SYNTHES VOLAR PLATE (SYNTHES INC, WEST CHESTER, PA). EXAMINATION SHOWED DIFFUSE SOFT TISSUE SWELLING AT THE VOLAR WRIST WITH RESTRICTION OF DIGITAL FLEXION AND INABILITY TO ACTIVELY MAKE A FIST. NERVE CONDUCTION STUDIES WERE SUGGESTIVE OF CARPAL TUNNEL SYNDROME. ON LATERAL X-RAY, THE PLATE APPEARED TO BE WELL-SEATED. THE PAIN, LOSS OF TENDON FUNCTION, AND CARPAL TUNNEL SYNDROME PROMPTED A RETURN TO SURGERY. SURGICAL FINDINGS INCLUDED FLEXOR TENOSYNOVITIS EXTENDING BEYOND THE PLATE EDGE AND HEMATOMA. SHE UNDERWENT RETRIEVAL OF THE HARDWARE, TENOSYNOVECTOMY OF ALL FLEXOR TENDONS AND RECURRENT CARPAL TUNNEL RELEASE. IN CONCLUSION, AS WITH ANY FRACTURE FIXATION METHOD, APPROPRIATE PATIENT SELECTION AND CAREFUL SURGICAL TECHNIQUE ARE NECESSARY FOR PREVENTING COMPLICATIONS INCLUDING INJURY TO THE FLEXOR TENDONS. PROCEDURE: OPEN REDUCTION AND INTERNAL FIXATION. PATIENT'S INFO: HAND INNOVATIONS DISTAL RADIUS PLATES: SYNTHES VOLAR PLATE (SYNTHES INC, WEST CHESTER, PA). AN (B)(6) YEAR-OLD WOMAN WITH PAIN IN THE RIGHT WRIST, STIFFNESS OF THE INDEX AND LONG FINGERS AND PARESTHESIAS IN THE MEDIAN NERVE DISTRIBUTION. EXAMINATION SHOWED DIFFUSE SOFT TISSUE SWELLING AT THE VOLAR WRIST WITH RESTRICTION OF DIGITAL FLEXION AND INABILITY TO ACTIVELY MAKE A FIST. NERVE CONDUCTION STUDIES WERE SUGGESTIVE OF CARPAL TUNNEL SYNDROME. SURGICAL FINDINGS INCLUDED FLEXOR TENOSYNOVITIS EXTENDING BEYOND THE PLATE EDGE AND HEMATOMA. TREATMENT NOTED: HAND INNOVATIONS DISTAL RADIUS PLATES: SYNTHES VOLAR PLATE (SYNTHES INC, WEST CHESTER, PA). THE PATIENT UNDERWENT RETRIEVAL OF THE HARDWARE, TENOSYNOVECTOMY OF ALL FLEXOR TENDONS AND RECURRENT CARPAL TUNNEL RELEASE. THIS REPORT IS FOR A SYNTHES VOLAR PLATE (SYNTHES INC, WEST CHESTER, PA). THIS IS REPORT 1 OF 1 FOR UNK - CONSTRUCTS: PLATE/ SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202430 UNK - CONSTRUCTS: PLATE/SCREWS PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention