BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4702364 · Received April 17, 2015

    Report

    Report Number
    2520274-2015-12678
    Event Type
    Malfunction
    Date Received
    April 17, 2015
    Report Date
    March 30, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN AO CLAVICULAR HOOK PLATE. 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: LI, N., LI, G., WANG, S., MA, C: (2011) AO CLAVICULAR HOOK PLATE FOR THE TREATMENT OF FRESH TOSSY TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION IN 28 PATIENTS. (B)(4) JOURNAL OF ORTHOPAEDICS AND TRAUMATOLOGY 24 (3) PG. 205-207. TO INVESTIGATE CLINICAL RESULTS OF AO CLAVICULAR HOOK PLATE FOR THE TREATMENT OF FRESH TOSSY TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION. FROM (B)(6) 2006 TO (B)(6) 2008, 28 PATIENTS WITH FRESH TOSSY TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION WERE TREATED WITH AO CLAVICULAR HOOK PLATES. THERE WERE 23 MALES AND 5 FEMALES. THE AVERAGE AGE AT SURGERY WERE 46.4 YEARS (RANGED, 22 TO 68 YEARS). THE AVERAGE TIME FROM SUFFERING INJURIES TO THE OPERATION WAS 3.9 DAYS(RANGED, 1 TO 21 DAYS). AND THE AVERAGE TIME FROM THE OPERATION TO PLATE REMOVAL WAS 9.4 MONTHS(RANGED, 6 TO 22 MONTHS). ALL THE PATIENTS WERE FOLLOWED UP, THE DURATION RANGED FROM 6 TO 24 MONTHS, WITH AN AVERAGE OF 15 MONTHS. THERE WAS 1 PATIENT WITH TRAUMATIC ARTHRITIS, 1 PATIENT WITH PLATE FRACTURE. AND THE OTHERS HAD GOOD RESULTS WITHOUT FRACTURE AND RE-DISLOCATION AFTER OPERATION. ACCORDING TO KARLSSON STANDARDS, 21 PATIENTS GOT AN EXCELLENT RESULT, 6 GOOD AND 1 POOR. EIGHT PATIENTS HAD PAIN AND RESTRICTED ACTIVITIES IN SHOULDER JOINTS BEFORE THE PLATE REMOVAL, AND ALL THE SYMPTOMS WERE CATABATIC AFTER REMOVING THE CLAVICULAR HOOK PLATES. AFTER EXERCISE, THE FUNCTION OF THE SHOULDER JOINTS ACHIEVED NORMAL LEVEL. CLAVICULAR HOOK PLATE USED FOR THE FRESH TOSSY TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION HAS ADVANTAGES SUCH AS SIMPLE OPERATION, LITTLE WOUND, LESS BLOOD LOSS AND EARLY EXERCISES. ONE PATIENT ENDED THE STUDY WITH A PLATE FRACTURE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO CLAVICULAR HOOK PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256834 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1