BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8065012 · Received November 13, 2018

    Report

    Report Number
    8030965-2018-58147
    Event Type
    Injury
    Date Received
    November 13, 2018
    Report Date
    October 26, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. (B)(4). THIS IMPACTED PRODUCT CAPTURES THE REPORTED (B)(6) MALE PATIENT WHO HAD RIGHT SIDE HAD CLAVICULAR HOOK PLATE FRACTURE. PATIENT HAD SLIGHT TENDERNESS. (RELEVANT TESTS/LAB DATA: FIGURE 1A INCLUDES PREOPERATIVE X-RAY FILM SHOWING TYPE TOSSY III ACROMIOCLAVICULAR JOINT DISLOCATION; FIGURE 1B INCLUDES POSTOPERATIVE X-RAY FILM SHOWING ANATOMICAL REDUCTION OF THE ACROMIOCLAVICULAR JOINT. FIGURE 1C INCLUDES AN X-RAY FILM TAKEN AT 22 MONTHS POST-OPERATIVELY SHOWING ANATOMICAL REDUCTION OF THE ACROMIOCLAVICULAR JOINT WITHOUT THE SIGNS OF OBVIOUS TRAUMATIC ARTHRITIS, AND THE STEEL PLATE BODY HAD FRACTURE AT DOWNWARD BENDING.) INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LI N, LI G, WANG SS, MA CM (2011). AO CLAVICULAR HOOK PLATE FOR THE TREATMENT OF FRESH TOSSY TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION IN 28 PATIENTS. ZHONGGUO GU SHANG/ CHINA JOURNAL OF ORTHOPAEDICS AND TRAUMATOLOGY. VOLUME 24. ISSUE 3. PAGES 205-207. (CHINA). THIS STUDY AIMS TO INVESTIGATE CLINICAL RESULTS OF AO CLAVICULAR HOOK PLATE FOR THE TREATMENT OF FRESH TOSSY TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION. BETWEEN DECEMBER 2006 TO DECEMBER 2008, 28 PATIENTS WITH FRESH TOSSY TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION WHO WERE TREATED WITH AN UNKNOWN AO CLAVICULAR HOOK PLATES WERE INCLUDED IN THE STUDY. THERE WERE 23 MALES AND 5 FEMALES WITH AN AVERAGE AGE OF 46.4 YEARS (RANGE, 22 TO 68 YEARS ). EVALUATION WAS ACCORDING TO THE CURATIVE EFFECT STANDARD OF KARLSSON ET AL.: EXCELLENT: THE SHOULDER APPEARANCE IS NORMAL WITHOUT DEFORMITY, NO PAIN OR TENDERNESS IS FOUND DURING MOVEMENT, THE MUSCLE STRENGTH IS NORMAL, THE SHOULDER JOINT CAN MOVE FREELY, AND THE WORK BEFORE INJURY IS RESTORED; X-RAY EXAMINATION SHOWS ANATOMICAL REDUCTION OF THE ACROMIOCLAVICULAR JOINT OR UPPER AND LOWER SUBLUXATION GAP SMALLER THAN 5MM, AND NO SIGNS OF TRAUMATIC ARTHRITIS ARE FOUND. GOOD: THE SHOULDER APPEARANCE IS NORMAL WITHOUT SIGNIFICANT DEFORMITY, DISCOMFORT OR SLIGHT PAIN IS FOUND AFTER FATIGUE, THE MUSCLE STRENGTH IS MODERATE, THE MOTION RANGE OF SHOULDER JOINT IS 90 TO 180 DEGREES, THE X-RAY EXAMINATION INDICATES ANATOMICAL REDUCTION OF JOINT OR UPPER AND LOWER SUBLUXATION GAP IN THE RANGE OF 5 TO 10 MM, AND NO SIGNIFICANT SIGNS OF TRAUMATIC ARTHRITIS ARE FOUND. POOR: THE SHOULDER APPEARANCE IS FREE OF OBVIOUS DEFORMITY, THE DISTAL CLAVICLE PROTRUDES UPWARD, PAIN IS SIGNIFICANT, THE MUSCLE STRENGTH IS POOR, THE SHOULDER JOINT ACTIVITY IS RESTRICTED IN ALL THE DIRECTIONS AND SMALLER THAN 90 DEGREES, THE X-RAY EXAMINATION STILL INDICATES ACROMIOCLAVICULAR JOINT DISLOCATION, THE ARTICULAR SURFACE IS NOT FLAT, AND THE JOINT SPACE BECOMES NARROWED AND BLURRED AND PRESENTS ARTHRITIS CHANGES. PATIENTS WERE FOLLOWED UP FOR A DURATION RANGED FROM 6 TO 24 MONTHS, AVERAGE OF 15 MONTHS. CLAVICULAR HOOK PLATES WERE REMOVED IN 6 TO 12 MONTHS AFTER THE OPERATION. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD CONCURRENT ACROMIOCLAVICULAR ARTHRITIS. 1 PATIENT HAD POOR SHOULDER JOINT FUNCTION PER KARLSSON CRITERIA (SHOULDER APPEARANCE IS FREE OF OBVIOUS DEFORMITY, THE DISTAL CLAVICLE PROTRUDES UPWARD, PAIN IS SIGNIFICANT, THE MUSCLE STRENGTH IS POOR, THE SHOULDER JOINT ACTIVITY IS RESTRICTED IN ALL THE DIRECTIONS AND SMALLER THAN 90 DEGREES, THE X-RAY EXAMINATION STILL INDICATES ACROMIOCLAVICULAR JOINT DISLOCATION, THE ARTICULAR SURFACE IS NOT FLAT, AND THE JOINT SPACE BECOMES NARROWED AND BLURRED AND PRESENTS ARTHRITIS CHANGES). 8 PATIENTS HAD SHOULDER JOINT PAINS AND JOINT MOTION DISORDERS AT DIFFERENT DEGREES, ESPECIALLY DURING ABDUCTION AND LIFTING. SYMPTOMS DISAPPEARED AFTER THE PLATE WAS REMOVED. THE JOINT FUNCTION RECOVERED WELL AND REACHED THE NORMAL RANGE AFTER THE PATIENTS UNDERWENT FUNCTIONAL EXERCISES. A (B)(6) MALE PATIENT WITH ACROMIOCLAVICULAR JOINT DISLOCATION OF TYPE TOSSY III ON THE RIGHT SIDE HAD CLAVICULAR HOOK PLATE FRACTURE FOUND WHEN THE PLATE WAS TAKEN OUT AT 22 MONTHS AFTER THE OPERATION. PATIENT HAD SLIGHT TENDERNESS IN THE ACROMIOCLAVICULAR REGION. X-RAY FILM SHOWED THE STEEL PLATE BODY TO HAVE A FRACTURE AT DOWNWARD BENDING. THIS REPORT IS FOR ONE (1) DEVICE ¿ UNKNOWN AO . THIS IS REPORT 2 OF 2 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904536 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention