BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 8611851 · Received May 15, 2019

    Report

    Report Number
    8030965-2019-63974
    Event Type
    Injury
    Date Received
    May 15, 2019
    Report Date
    April 17, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PMA/510(K): THIS REPORT IS FOR UNKNOWN PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: PETERSEN W (2014). OSTEOCHONDRAL TRANSPLANTATION FOR THE TREATMENT OF OSTEOCHONDRAL DEFECTS AT THE TALUS WITH THE DIAMOND TWIN SYSTEM AND GRAFT HARVESTING FROM THE POSTERIOR FEMORAL CONDYLES. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY. VOLUME 134. PAGE 843-852. (GERMANY). THE AIM OF THIS STUDY IS TO ANALYZE RADIOLOGICAL, ARTHROSCOPICAL, AND CLINICAL RESULTS AFTER OSTEOCHONDRAL TRANSPLANTATION FOR DEFECTS AT THE TALUS USING THE DIAMOND TWIN SYSTEM. THE GRAFTS WERE HARVESTED FROM THE POSTERIOR FEMORAL CONDYLES OF THE IPSILATERAL KNEE. BETWEEN 2008 AND 2011, 20 PATIENTS WHO HAD BEEN TREATED BY AUTOLOGOUS OSTEOCHONDRAL GRAFTING FOR SYMPTOMATIC OSTEOCHONDRAL DEFECTS OF THE TALUS WERE INCLUDED IN THE STUDY. THERE WERE 12 MEN AND 8 WOMEN WITH A MEAN AGE OF 25.4 YEARS (18-44 YEARS). PATIENTS UNDERWENT GRAFT HARVESTING AT THE KNEE WITH OSTEOCHONDRAL CYLINDER TRANSPLANTATION USING A COMPETITOR¿S DEVICE. IN 19 PATIENTS, A MEDIAL MALLEOLAR OSTEOTOMY WAS PERFORMED AND THE OSTEOTOMY WAS RIGIDLY FIXED USING EITHER UNKNOWN TITANIUM SCREWS (MEDIAL MALLEOLUS). MEANWHILE, IN 1 PATIENT, A LATERAL FIBULAR OSTEOTOMY WAS PERFORMED BELOW THE SYNDESMOSIS AND WAS FIXATED WITH AN UNKNOWN AO ONE-THIRD TUBULAR PLATE FOR THE FIBULA. THE FIRST FOLLOW-UP WAS THE TIME OF IMPLANT REMOVAL WHICH WAS PERFORMED IN ALL PATIENTS. IN 15 CASES, A SECOND-LOOK ARTHROSCOPY WAS PERFORMED AT THIS TIME POINT. THE INDICATION FOR SECOND-LOOK ARTHROSCOPY WAS ANKLE PAIN. ONE FOLLOW-UP EXAMINATION WAS PERFORMED AFTER A MEAN OF 12.6 MONTHS AND A SECOND FOLLOW-UP WAS PERFORMED AT A MINIMUM OF 24 MONTHS (MEAN 25.8 MONTHS) AFTER SURGERY. THE ARTICLE DID NOT SPECIFY WHICH OF THE PATIENTS WAS IMPLANTED WITH AN UNKNOWN AO PLATE FOR THE FIBULA. THUS, COMPLICATIONS WILL BE REPORTED AS FOLLOWS: 5 PATIENTS HAD A DECREASED RANGE OF MOVEMENT OF THE ANKLE (>5° OF FLEXION OR EXTENSION IN COMPARISON TO THE CONTRALATERAL SIDE). 15 PATIENTS HAD ADHESIONS AND SYNOVITIS IN THE ANTERIOR ANKLE COMPARTMENT AT SECOND-LOOK ARTHROSCOPY. A PARTIAL SYNOVECTOMY AND ARTHROLYSIS WERE PERFORMED IN ALL THESE PATIENTS. THIS REPORT IS FOR UNKNOWN AO ONE-THIRD TUBULAR PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406070 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention