BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3932725 · Received July 14, 2014

    Report

    Report Number
    2520274-2014-12237
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. JAKUBIETZ, M., GRUENERT, J., JAKUBIETZ, R. (2011) THE USE OF BETA-TRICALCIUM PHOSPHATE BONE GRAFT SUBSTITUTE IN DORSALLY PLATE, COMMINUTED DISTAL RADIUS FRACTURES. J ORTHO SURG RES 6:24. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN DORSAL PI-PLATES. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 JOURNAL ARTICLE: THE USE OF BETA-TRICALCIUM PHOSPHATE BONE GRAFT SUBSTITUTE IN DORSALLY PLATE, COMMINUTED DISTAL RADIUS FRACTURES. JAKUBIETZ, M., GRUENERT, J., JAKUBIETZ, R. (2011) THE USE OF BETA-TRICALCIUM PHOSPHATE BONE GRAFT SUBSTITUTE IN DORSALLY PLATE, COMMINUTED DISTAL RADIUS FRACTURES. J ORTHO SURG RES 6:24. THIS WAS A PROSPECTIVE RANDOMIZED STUDY OF 39 PATIENTS (MEAN AGE OF 67.7 YEARS) WITH UNILATERAL INTRAARTICULAR FRACTURES OF THE DISTAL RADIUS. PATIENTS WERE RANDOMIZED TO EITHER GROUP I, WHICH RECEIVED A DORSAL IMPLANT ONLY (PI-PLATE, SYNTHES), OR GROUP II WHICH RECEIVED BONE AUGMENTATION WITH GRANULAR BETA-TRICALCIUM (CHRONOS, SYNTHES) IN ADDITION TO THE IMPLANT. GRADE II BEGINNING DEGENERATIVE, POSTTRAUMATIC OSTEOARTHROSIS WAS SEEN IN ONE PATIENT IN EACH GROUP AND GRADE I WAS SEEN IN 9 PATIENTS IN EACH GROUP. COMPLICATIONS SUCH AS SECONDARY DISPLACEMENT OF A FRAGMENT AND INTRAARTICULAR STEPS GREATER THAN 2 MM OCCURRED IN A TOTAL OF 7 PATIENTS. IN FIVE PATIENTS, THE DISLOCATION REQUIRED SECONDARY OSTEOSYNTHESIS WITH A FIXED ANGLE VOLAR PLATE. DEVELOPING COMPLEX REGIONAL PAIN SYNDROME WAS DIAGNOSED IN 8 PATIENTS AND SUCCESSFULLY TREATED WITH CORTISONE. EXTENSOR TENDON RUPTURES OCCURRED IN 3 PATIENTS AND REQUIRED OPERATIVE TREATMENT. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN DORSAL PI-PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409401 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention