BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PLATE

    MDR report key: 4827514 · Received June 9, 2015

    Report

    Report Number
    2520274-2015-14336
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Report Date
    May 29, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ¿ORTHODONTIC SKELETAL ANCHORAGE USING A PALATAL EXTERNAL PLATE¿. KOBAYASHI, M., AND FUSHIMA, K. JOURNAL OF ORTHODONTICS, VOL 41, (2014) PAGE 53-62. 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: ORTHODONTIC SKELETAL ANCHORAGE USING A PALATAL EXTERNAL PLATE. KOBAYASHI, M., AND FUSHIMA, K. JOURNAL OF ORTHODONTICS, VOL 41, (2014) PAGE 53-62. USING EXTERNAL PLATE SYSTEM WAS DEVELOPED AS A TEMPORARY SKELETAL ANCHORAGE DEVICE UTILIZING THE CRANIO-MAXILLOFACIAL IMPLANT COMPACT LOCK (SYNTHES CO., SOLOTHURN, SWITZERLAND), AND NAMED ANCHOR-LOCK. ONE HUNDRED AND THIRTY-SEVEN CONSECUTIVE PATIENTS, 104 FEMALES AND 33 MALES WHO VISITED THE KANAZAWA ORTHODONTIC CLINIC FROM 2004 TO 2012 AND RECEIVED THE ANCHOR-LOCK AS ORTHODONTIC SKELETAL ANCHORAGE, PARTICIPATED IN THE STUDY. THE MEDIAN AGE WAS 20 YEARS, RANGING FROM 10 TO 54 YEARS. ELEVEN OF THE 137 FAILED. TEN FEMALES AND ONE MALE. ONE FEMALE SUBJECT AGED (B)(6) YEARS WITH OVER-EXPANDED LATERAL TEETH THAT HAD RELAPSED SPONTANEOUSLY TO SOME EXTENT. IN ALL EXCEPT TWO CASES, THE DEVICE WAS REMOVED SOON AFTER APPLICATION, WITH A TIME FAILURE OF LESS THAN 4 MONTHS. COUNTRY OF ORIGIN IS JAPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371924 BONE PLATE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1