BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5856367 · Received August 9, 2016

    Report

    Report Number
    2520274-2016-13936
    Event Type
    Injury
    Date Received
    August 9, 2016
    Report Date
    August 1, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MIZUSEKI, T., TSUGE, K., AND IKUTA, Y. (2001). PRECISE ULNA-SHORTENING OSTEOTOMY WITH A NEW DEVICE. JOURNAL OF HAND SURGERY. 26A(5), PP 931-939. THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT/QUANTITY OF 6. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE MIZUSEKI, T., TSUGE, K., AND IKUTA, Y. (2001). PRECISE ULNA-SHORTENING OSTEOTOMY WITH A NEW DEVICE. JOURNAL OF HAND SURGERY. 26A(5), PP 931-939. THIS STUDY REPRESENTS A RETROSPECTIVE RADIOGRAPHIC ASSESSMENT OF ALL PATIENTS WHO UNDERWENT ULNAR SHORTENING AT THE AUTHORS' CENTER WITH THEIR DEVICE BETWEEN FEBRUARY 1996 AND JUNE 1999. TWENTY-FOUR ULNAS IN 23 PATIENTS WERE INCLUDED. THERE WERE 8 MEN AND 15 WOMEN WITH AN AGE RANGE FROM 18 TO 64 YEARS (MEAN, 40 YEARS). THE PLATE FOR FIXATION OF THE ULNA IS A 5-HOLE 3.5-MM SYNTHES DYNAMIC COMPRESSION PLATE (DCP). THE AVERAGE FOLLOW-UP PERIOD WAS 36 MONTHS. NO DELAYED UNIONS OR NON-UNIONS OCCURRED. IN 6 CASES DIFFUSE TENDERNESS ALONG THE PLATE, ESPECIALLY NEAR THE EXTENSOR CARPI ULNARIS TENDON, WAS NOTED AFTER HEAVY USE OF THE HAND. THIS TENDERNESS WAS DIFFERENTIATED FROM CLINICAL SIGNS OF DELAYED UNION BECAUSE IT RESOLVED AFTER REST. WE CONSIDER THIS DIFFUSE TENDERNESS PLATE IRRITATION AS THE THICKNESS OF THE PLATE DISRUPTS SMOOTH GLIDING OF THE EXTENSOR CARPI ULNARIS WHILE THE WRIST IS FLEXED OR EXTENDED. THIS TENDERNESS RESOLVED IMMEDIATELY AFTER PLATE REMOVAL. THIS REPORT IS FOR AN UNKNOWN DYNAMIC COMPRESSION PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512690 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention