BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES

    MDR report key: 10610212 · Received September 30, 2020

    Report

    Report Number
    8030965-2020-07573
    Event Type
    Injury
    Date Received
    September 30, 2020
    Report Date
    September 8, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION 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. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: AKRAA M, ET AL. (2019), OSTEOSYNTHESIS OF ANKLE FRACTURES: PROBLEMS AND SOLUTIONS, INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH, VOLUME 11, ISSUE 3, PAGES 405-4011, (RUSSIA). THE AIM OF THIS STUDY WAS TO EXAMINE THE POSSIBILITIES OF IMPROVING THE RESULTS OF SURGICAL TREATMENT OF PATIENTS WITH ANKLE FRACTURES WITH MINIMALLY INVASIVE OSTEOSYNTHESIS TECHNOLOGIES. DURING THE PERIOD FROM 2000 TO 2017, 62 PATIENTS WITH ANKLE FRACTURES WERE MONITORED AND INCLUDED IN THE STUDY. 2 GROUPS OF PATIENTS WITH INJURIES OF THE ANKLE JOINT WERE FORMED. IN THE FIRST GROUP, WHERE OPEN OSTEOSYNTHESIS WAS PERFORMED, SURGICAL TREATMENT WAS CARRIED OUT ON 28 PATIENTS ACCORDING TO THE STANDARD AO TECHNIQUE. THESE PATIENTS UNDERWENT LATERAL ANKLE FIXATION USING AN UNKNOWN SYNTHES LOCKING COMPRESSION PLATE. WHEN THE DISTAL TIBIOFIBULAR SYNDESMOSIS WAS RUPTURED, THE LATTER WAS FIXED WITH A POSITION SCREW. OSTEOSYNTHESIS OF THE MEDIAL ANKLE WAS CARRIED OUT USING WEBER¿S METHOD OR SCREWS. IN THE SECOND GROUP OF PATIENTS, WHERE CLOSED OSTEOSYNTHESIS WAS PERFORMED, 34 PATIENTS WERE INCLUDED. FOR ISOLATED AND COMBINED FRACTURES OF THE MEDIAL ANKLE, ORIGINAL OSTEOSYNTHESIS WAS APPLIED WITH STRAINED V-SHAPED SPOKES. ON THE SECOND DAY AFTER THE OPERATION, ACTIVE PHYSIOTHERAPY EXERCISES BEGAN WITHOUT EXTERNAL IMMOBILIZATION. EVERY 2 MONTHS FROM THE MOMENT OF OSTEOSYNTHESIS, OUTPATIENT RADIOLOGICAL MONITORING WAS PERFORMED UNTIL THE FRACTURES WERE CONSOLIDATED. COMPLICATIONS WERE REPORTED AS FOLLOWS: 14 PATIENTS HAD NECROSIS OF WOUND EDGES. 6 PATIENTS HAD INFLAMMATORY COMPLICATIONS. 4 PATIENTS HAD A FALSE JOINT. THIS REPORT IS FOR THE UNKNOWN SYNTHES LOCKING COMPRESSION PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072194 UNK - PLATES PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention