BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5539076 · Received March 31, 2016

    Report

    Report Number
    2520274-2016-11869
    Event Type
    Injury
    Date Received
    March 31, 2016
    Report Date
    March 11, 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 USED FOR TREATMENT, NOT DIAGNOSIS. WINKER, K.H. (2005). ¿ANGULAR STABLE PLATE SYSTEMS IN THE DISTAL RADIUS: SOLUTIONS AND PROBLEMS.¿ AKT TRAUMATOL (2005) 35: 151-154. THIS REPORT IS FOR UNKNOWN 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 JOURNAL ARTICLE, WINKER, K.H. (2005). ¿ANGULAR STABLE PLATE SYSTEMS IN THE DISTAL RADIUS: SOLUTIONS AND PROBLEMS.¿ AKT TRAUMATOL (2005) 35: 151-154. THE ARTICLE WAS BASED ON A RETROSPECTIVE (YEARS 1996,1997) AND PROSPECTIVE STUDY (1998 AND FORWARD) OF 100 DISTAL RADIUS EXTENSION FRACTURES WHO WERE SURGICALLY TREATED USING ONE OF THREE PLATING SYSTEMS; RADIUS T-PLATE, DISTAL RADIUS PLATE, AND LCP PLATE. THE PURPOSE OF THE STUDY WAS TO DETERMINE THE BENEFITS AND PROBLEMS WITH THE PLATING SYSTEMS. THE FOLLOWING COMPLICATIONS WERE NOTED AS GENERAL COMPLICATIONS NOT ASSOCIATED WITH ANY PARTICULAR PLATE TYPE: 10 INSTANCES OF CORRECTION LOSS; LOSS OF REDUCTION POST-OPERATIVELY, 2 CASES OF INFECTION, 2 CASES OF KTS; CARPAL TUNNEL. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193437 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention