BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: LCP PROXIMAL TIBIAL PLATE

    MDR report key: 15971022 · Received December 13, 2022

    Report

    Report Number
    8030965-2022-11020
    Event Type
    Injury
    Date Received
    December 13, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THIS REPORT IS FOR AN UNKNOWN PLATES: LCP PROXIMAL TIBIAL PLATE /UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: JIANBIN S., ZHIZHONG L., (2022), LOCK SHEET EXTERNAL AND EXTERNAL MOUNT TREATMENT TSCHERNE I, N-TYPE (FIBULA) BONE FRACTURE COMPARISON ANALYSIS, NINGXIA MEDICAL JOURNAL (2022), VOL 44 (4) 354¿357 (CHINA). THE PURPOSE OF THIS STUDY IS TO ANALYZE THE EFFECTS OF TWO SURGICAL METHODS OF TREATING TSCHERNE L, N TIBIA (FIBULA) BONE FRACTURE. FROM JULY 2015 TO JULY 2018, 81 PATIENTS WITH TIBIA FRACTURE SURGERY OF TYPE TSCHERNE I AND N WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS; GROUP A WITH EXTERNAL FIXATION OF LOCKING PLATE AND GROUP B WITH EXTERNAL FIXATION OF EXTERNAL FIXATION FRAME. IN GROUP A, THERE WERE 30 MEN AND 13 WOMEN WITH AGES 23 TO 67 YEARS, AVERAGE (44.07+/-10.84 YEARS). THESE PATIENTS UNDERWENT SURGERY USING AN UNKNOWN SYNTHES LOCKING COMPRESSION PLATE PROXIMAL TIBIAL LATERAL BONE PLATE. IN GROUP B, THERE WERE 25 MEN AND 13 WOMEN WITH AGES 20 TO 62 YEARS, AVERAGE (41.42 +/- 9.94 YEARS). THESE PATIENTS WERE SECURED WITH A COMPETITOR'S EXTERNAL FIXATION BRACKET (MANUFACTURER: CHANZHOU HUASEN CO. LTD). COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A: 3 PATIENTS HAD A FRACTURE DOES NOT HEAL. 2 PATIENTS HAD AN INCISION INFECTION. 5 PATIENTS HAD A LOOSE SCREWS. THIS REPORT INVOLVES ONE UNK - PLATES: LCP PROXIMAL TIBIAL PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407081 UNK - PLATES: LCP PROXIMAL TIBIAL PLATE PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention