BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCK TUBULAR PL 6H 82MM

    MDR report key: 8020596 · Received October 30, 2018

    Report

    Report Number
    1020279-2018-02296
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 2, 2018
    Report Date
    May 4, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    03596010523211
    PMA / PMN Number
    K033669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, THE RADIOLOGICAL IMAGING REPORT DATED 07/31/2018 (APPROXIMATELY 8 WEEKS POST ORIF) NOTED ¿THE PLATE AND SCREW FIXATION OF THE ULNAR BONE DEMONSTRATES FRACTURING OF THE MID PLATE. THIS IS ASSOCIATED WITH ANGULATION OF THE DISTAL BONY FRAGMENT AND NON-UNION¿. THE PROVIDED UNDATED / UNIDENTIFIED AP/LAT IMAGES SUPPORT THE FRACTURED ULNAR PLATE. NO REVISION SURGERY HAS BEEN PERFORMED YET, AS IT WAS COMMUNICATED THAT THE SURGEON WANTS TO WAIT FOR HEALING PRIOR TO REMOVAL. NO FURTHER CLINICALLY RELEVANT SUPPORTING DOCUMENTATION WAS PROVIDED FOR INCLUSION IN THIS MEDICAL INVESTIGATION. IN CONCLUSION: BOTH THE RADIOLOGICAL REPORT AND ELECTRONIC COPY OF THE AP/LAT IMAGES SUPPORT THE COMPLAINT OF A BROKEN ULNAR PLATE, HOWEVER, IMMEDIATE POST-OP IMAGES WERE NOT AVAILABLE FOR COMPARISON. THE ROOT CAUSE OF THE ULNAR PLATE FRACTURE COULD NOT DEFINITIVELY BE DETERMINED BASED ON THIS LIMITED INFORMATION. EARLY WEIGHT-BEARING PRIOR TO FULL BONY-UNION IS A KNOWN CAUSE OF HARDWARE FAILURE AND CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE PATIENT IMPACT BEYOND PROBABLE DISCOMFORT, DELAYED HEALING OF THE ULNAR BONE, AND FUTURE HARDWARE REMOVAL WITH AN EXPECTED BRIEF POST-OPERATIVE REHABILITATION CANNOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE CORRESPONDING PRODUCTS DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCH. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SERIOUS HAS OCCURED. THE PATIENT HAD FOREARM PLATES DONE, HE REPORTED PLATE BROKE. CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862432 3.5MM LCK TUBULAR PL 6H 82MM PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 17LT94828 03596010523211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R