BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3679824 · Received March 14, 2014

    Report

    Report Number
    2520274-2014-10263
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Report Date
    February 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ARORA, R. ET AL (2012). BEHAVIOUR OF CHRONOS INJECT IN METAPHYSEAL BONE DEFECTS OF DISTAL RADIUS FRACTURES: TISSUE REACTION AFTER 6-15 MONTHS. INJURY, INT. J. CARE INJURED, 43, 1683-1688. THIS REPORT IS FOR AN UNKNOWN 2.4 MILLIMETER LOCKING COMPRESSION PLATE DISTAL RADIUS PLATE. 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: ARORA, R. ET AL (2012). BEHAVIOUR OF CHRONOS INJECT IN METAPHYSEAL BONE DEFECTS OF DISTAL RADIUS FRACTURES: TISSUE REACTION AFTER 6-15 MONTHS. INJURY, INT. J. CARE INJURED, 43, 1683-1688. THE AUTHORS STUDIED SIX PATIENTS (THREE MEN AND THREE WOMEN) WITH A MEAN AGE OF 70 YEARS (RANGE, 62-81 YEARS) BETWEEN 2006 AND 2008 WITH A DORSALLY DISPLACED DISTAL RADIUS FRACTURE WHO WERE TREATED WITH SYNTHES CHRONOS INJECT APPLICATION INTO THE METAPHYSEAL BONE DEFECT AND OPEN REDUCTION AND A VOLAR LOCKING PLATE, SYNTHES 2.4 MILLIMETER LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS PLATE. DURING IMPLANT REMOVAL (AVERAGE 11 MONTHS), A TWO MILLIMETER DIAMETER BIOPSY WAS OBTAINED FROM THE REGION OF THE PREVIOUS CEMENT INJECTION FOR EVALUATION. TWO PATIENTS REQUIRED IMPLANT REMOVAL DUE TO FLEXOR TENDON IRRITATION. A 70 YEAR OLD MALE EXPERIENCED LOSS OF REDUCTION POST-OPERATIVELY DUE TO A HIGHLY COMMINUTED AND UNSTABLE SITUATION WHICH COULD NOT BE NEUTRALIZED WITH THE LOCKING PLATE RESULTING IN A DORSAL TILT OF 25 DEGREES. THE AUTHORS REPORTED THAT SMALL AMOUNTS OF CHRONOS INJECT WERE DETECTABLE IN HUMAN PATIENTS 15 MONTHS AFTER IMPLANTATION INTO A DISTAL RADIUS BONE DEFECT, INDICATING CHRONOS INJECT WAS INTEGRATED INTO THE NEWLY FORMED TRABECULAR BONE NETWORK. THIS IS A SERIOUS INJURY/REPORTABLE MALFUNCTION REPORT FOR ONE PATIENT: A (B)(6) MALE EXPERIENCED LOSS OF REDUCTION POST-OPERATIVELY DUE TO A HIGHLY COMMINUTED AND UNSTABLE SITUATION WHICH COULD NOT BE NEUTRALIZED WITH THE LOCKING PLATE RESULTING IN A DORSAL TILT OF 25 DEGREES. THIS IS REPORT 2 OF 2 FOR COMPLAINT COM¿041625. THIS REPORT IS FOR AN UNKNOWN 2.4 MILLIMETER LCP DISTAL RADIUS PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152813 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention