BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5409796 · Received February 4, 2016

    Report

    Report Number
    2520274-2016-10753
    Event Type
    Injury
    Date Received
    February 4, 2016
    Report Date
    January 15, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. VAN HEEST, A.E. AND STROTHMAN, D. (2009). WRIST ARTHRODESIS IN CEREBRAL PALSY. JHS, 34A, 1216-1224 THIS REPORT IS FOR AN UNKNOWN WRIST FUSION PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. 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. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, VAN HEEST, A.E. AND STROTHMAN, D. (2009). WRIST ARTHRODESIS IN CEREBRAL PALSY. JHS, 34A, 1216-1224. THE AUTHORS CONDUCTED A RETROSPECTIVE REVIEW OF CHARTS AND RADIOGRAPHS TO EXAMINE THE RESULTS OF WRIST ARTHRODESIS USING SYNTHES WRIST FUSION PLATE IN THE TREATMENT OF SKELETALLY MATURE PATIENTS WITH CEREBRAL PALSY FOR SEVERE, FIXED WRIST FLEXION DEFORMITY. RESULTS WERE MEASURED BY FUSION RATE, COMPLICATIONS, AND CLINICAL OUTCOMES. BETWEEN 1995 AND 2007, 34 PATIENTS (41 EXTREMITIES) WITH DEFORMITIES ASSOCIATED WITH CEREBRAL PALSY WERE TREATED BY WRIST ARTHRODESIS USING DORSAL PLATE FIXATION. THE 34 PATIENTS IN THIS STUDY CONSISTED OF 23 MALE AND 11 FEMALE PATIENTS. THE AVERAGE AGE AT THE TIME OF SURGERY WAS 22 YEARS (RANGE, 13-50 YEARS) WITH AVERAGE FOLLOW-UP OF 14 MONTHS (RANGE, 2-70 MONTHS). RESULTS INCLUDED: PLATE IRRITATION REQUIRING HARDWARE REMOVAL AFTER UNION (18 PATIENTS), INCLUDING ONE DUE TO EXTENSOR TENDON TENOSYNOVITIS WHICH SUBSEQUENTLY RESOLVED AFTER HARDWARE REMOVAL; AND FRACTURES (THREE RADIUS) THROUGH SCREW HOLES WITH SUBSEQUENT HARDWARE REMOVAL AND OPEN REDUCTION INTERNAL FIXATION. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN WRIST FUSION PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67908 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention