BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE FIXATION, BONE

    MDR report key: 8279447 · Received January 25, 2019

    Report

    Report Number
    8030965-2019-60396
    Event Type
    Injury
    Date Received
    January 25, 2019
    Report Date
    January 7, 2019
    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

    THIS REPORT IS FOR AN UNKNOWN SYNTHES AO HOOK PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. 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: XIONG, J. ET AL (2018), TREATMENT OF UNSTABLE DISTAL CLAVICLE FRACTURES (NEER TYPE II): A COMPARISON OF THREE INTERNAL FIXATION METHODS, JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, VOL. 46(11), PAGES 1-6 (CHINA). THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE CLINICAL EFFICACY OF THREE INTERNAL FIXATION METHODS FOR DISTAL CLAVICLE FRACTURES (NEER TYPE II): CLAVICULAR HOOK PLATE (GROUP A), ANATOMICAL PLATE (GROUP B), AND ARTHROSCOPIC ENDOBUTTON (GROUP C). BETWEEN 2001 AND 2014, A TOTAL OF 58 PATIENTS (34 MALE AND 24 FEMALE) WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO 3 GROUPS BASED ON THE FIXATION METHOD: PATIENTS IN GROUP A (AO HOOK PLATE; SYNTHES SOLOTHURN, SWITZERLAND) CONSISTED OF 25 PATIENTS WITH A MEAN AGE OF 46.5±15.8 YEARS, THOSE IN GROUP B (AO DISTAL CLAVICLE ANATOMIC LOCKING PLATE; SYNTHES) CONSISTED OF 5 PATIENTS WITH A MEAN AGE OF 38.0±14.7 YEARS AND THOSE IN GROUP C (COMPETITOR¿S DEVICE) CONSISTED OF 28 PATIENTS WITH A MEAN AGE OF 41.9±13.5 YEARS. ALL PATIENTS WERE FOLLOWED-UP AND RADIOGRAPHS WERE TAKEN TO EVALUATE FRACTURE HEALING. THE AVERAGE FOLLOW-UP PERIOD WAS 57 MONTHS (RANGE, 7-160 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOW UNDER GROUP A: 8 PATIENTS OF WHICH THE CORACOCLAVICULAR LIGAMENTS WITH SUTURES WHICH COMPLETELY RUPTURED WERE REPAIRED. 15 PATIENTS OF WHICH THE HOOK PLATES WERE REMOVED AT AN AVERAGE OF 18.8 MONTHS AFTER SURGERY. 1 PATIENT THE HOOK PLATE COULD NOT BE REMOVED BECAUSE OF TOTAL LOCKING BETWEEN THE SCREW AND PLATE. IN THIS PATIENT, SHOULDER DISCOMFORT PERSISTED UNTIL THE LAST FOLLOW-UP. UNKNOWN PATIENTS COMPLAINED OF FOREIGN BODY AND/OR IMPINGEMENT SENSATIONS FROM THE IMPLANTS; THESE SENSATIONS RESOLVED IN 14 PATIENTS AFTER REMOVAL OF THE HOOK PLATES. 2 PATIENTS DEVELOPED FRACTURES PROXIMAL TO THE IMPLANT AT 10 DAYS AND 4 WEEKS POSTOPERATIVELY, RESPECTIVELY. BOTH FRACTURES HEALED AFTER FIXATION WITH ANATOMIC AND RECONSTRUCTIVE PLATES. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOW UNDER GROUP B: 5 PATIENTS WHICH THE CORACOCLAVICULAR LIGAMENTS WITH SUTURES WHICH COMPLETELY RUPTURED WERE REPAIRED. THIS REPORT CAPTURES THE FOLLOWING ADVERSE EVENTS: CORACOCLAVICULAR LIGAMENTS WITH SUTURES WHICH COMPLETELY RUPTURED. HOOK PLATES WERE REMOVED AT AN AVERAGE OF 18.8 MONTHS AFTER SURGERY, SHOULDER DISCOMFORT, FOREIGN BODY AND/OR IMPINGEMENT SENSATIONS, DEVELOPED FRACTURES PROXIMAL TO THE IMPLANT. THIS REPORT IS FOR AN UNKNOWN SYNTHES AO HOOK PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70952 PLATE FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention