BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8030494 · Received November 1, 2018

    Report

    Report Number
    8030965-2018-57831
    Event Type
    Injury
    Date Received
    November 1, 2018
    Report Date
    October 19, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDED IN THE JOURNAL ARTICLE. 510K: THIS REPORT IS FOR UNKNOWN AO CLAVICULAR HOOK PLATES /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THERE ARE MULTIPLE UNKNOWN DATES OF IMPLANTATION BETWEEN MARCH 2000 AND APRIL 2005. THERE ARE MULTIPLE UNKNOWN DATES OF EXPLANTATION. 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. 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. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WU JH, ET AL (2006). CLAVICULAR HOOK PLATE IN THE TREATMENT OF DISLOCATION OF ACROMIOCLAVICULAR JOINT AND FRACTURE OF DISTAL CLAVICLE. JOURNAL OF CENTRAL SOUTH UNIVERSITY (MEDICAL EDITION). VOLUME 31. PAGES 595-598. ((B)(6)) . THIS STUDY AIMS TO EVALUATE THE CURATIVE EFFECTS OF AO CLAVICULAR HOOK PLATE IN THE TREATMENT OF DISLOCATION OF ACROMIOCLAVICULAR JOINT AND FRACTURE OF DISTAL CLAVICLE. BETWEEN MARCH 2000 AND APRIL 2005, 39 PATIENTS WITH ACROMIOCLAVICULAR JOINT DISLOCATION OR DISTAL CLAVICLE FRACTURE WHO WERE TREATED WITH CLAVICULAR HOOK PLATE WERE INCLUDED IN THE STUDY. THERE WERE 27 MALES AND 12 FEMALES, WITH AN AVERAGE AGE OF 37 YEARS OLD (RANGE, 18 TO 56). ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN AO CLAVICULAR HOOK PLATE MATCHED WITH UNKNOWN CORTICAL OR CANCELLOUS SCREWS. SHOULDER FUNCTION EXERCISES WERE STARTED, AND X-RAY EXAMINATIONS WERE PERFORMED AT THREE (3) DAYS AFTER SURGERY. FOLLOW-UP VISITS WERE PERFORMED FROM 3 MONTHS TO 2 YEARS (12 MONTHS ON THE AVERAGE). COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD A SENSE OF SORENESS AT THE ACROMION DURING SHOULDER JOINT ACTIVITY. THE SYMPTOM DISAPPEARED AFTER THE INTERNAL FIXATION WAS REMOVED AND FUNCTIONAL EXERCISE WAS COMPLETED. 1 PATIENT STILL HAD AN ACROMIOCLAVICULAR JOINT DISLOCATION POST-OPERATIVELY. PATIENT WAS REVISED WITH CLAVICULAR HOOK PLATE FIXATION. THIS REPORT IS FOR UNKNOWN AO CLAVICULAR HOOK PLATES. THIS IS REPORT 1 OF 1 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
    869358 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention