BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7600630 · Received June 14, 2018

    Report

    Report Number
    8030965-2018-54329
    Event Type
    Injury
    Date Received
    June 14, 2018
    Report Date
    May 29, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN 4.5 MM BUTTRESSING PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT/EXPLANT IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: BERTRAND, M.L., PASCUAL-LÓPEZ, F.J., GUERADO, E. (2017), SEVERE TIBIAL PLATEAU FRACTURES (SCHATZKER V-VI): OPEN REDUCTION AND INTERNAL FIXATION VERSUS HYBRID EXTERNAL FIXATION. INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, VOLUME 48, PAGES S81¿S85 (SPAIN) THE AIM OF THIS STUDY IS TO EXAMINE THE OUTCOMES OF USING OPEN REDUCTION INTERNAL FIXATION (ORIF) VERSUS HYBRID EXTERNAL FIXATION (HEF) IN THESE SEVERE-TYPE OF FRACTURES, V AND VI FRACTURES IN WHICH, ORIF OBTAINS BETTER REDUCTIONS WHILE HEF IS LESS LIKELY TO PROVOKE COMPLICATIONS. BETWEEN 1995 AND 2013, 93 PATIENTS (66 MALES AND 27 FEMALES) WITH UPPER TIBIA SEVERE TYPE V OR VI FRACTURES WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE GROUPED INTO TWO. GROUP A WITH 26 PATIENTS WHO WERE EACH IMPLANTED WITH 2 UNKNOWN SYNTHES BUTTRESSING PLATES, IN 13 CASES ADDITIONAL CANNULATED SCREWS WERE IMPLANTED FOR JOINT STABILIZATION. GROUP B WITH 67 PATIENTS WHO WERE IMPLANTED WITH A COMPETITOR DEVICE AS A HYBRID EXTERNAL FIXATOR. ALL PATIENTS UNDERWENT THE SAME POSTOPERATIVE REGIMEN, AND WERE CLINICALLY AND RADIOLOGICALLY FOLLOWED UP AT 3, 6, 18, AND 24 MONTHS. THESE REPORTED COMPLICATIONS REPRESENT THE PATIENTS IN GROUP A WHO WERE IMPLANTED WITH UNKNOWN SYNTHES BUTTRESSING PLATES. FIVE (5) PATIENTS HAD A FIXED FLEXION DEFORMITY (EXTENSION DEFICIT) OF >10°. ONE (1) PATIENT HAD FLEXION OF <90°. TWELVE (12) PATIENTS HAD FLEXION OF >120°. ONE (1) PATIENT HAD SUPERFICIAL INFECTION. TWO (2) PATIENTS HAD DEEP INFECTION. TWO (2) PATIENTS HAD DELAY IN CONSOLIDATION. FIVE (5) PATIENTS HAD SECONDARY MALALIGNMENT. ONE (1) PATIENT UNDERWENT MOBILIZATION UNDER ANESTHESIA. ONE (1) PATIENT UNDERWENT ARTHROSCOPIC ARTHROLYSIS. THREE (3) PATIENTS UNDERWENT SURGICAL DEBRIDEMENT. THIS REPORT IS FOR AN UNKNOWN 4.5 MM BUTTRESSING PLATE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443623 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention