BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP

    MDR report key: 12319943 · Received August 13, 2021

    Report

    Report Number
    8030965-2021-06674
    Event Type
    Injury
    Date Received
    August 13, 2021
    Report Date
    July 16, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LCP CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER: (B)(6). REPORTER FAX NUMBER: (B)(6). 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: KAO, F.C. ET AL. (2010), TREATMENT OF DISTAL TIBIAL FRACTURES BY MINIMALLY INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS OF THREE DIFFERENT PLATES: RESULTS AND COST-EFFECTIVENESS ANALYSIS, FORMOSAN JOURNAL OF MUSCULOSKELETAL DISORDERS, VOL. 1, PAGES 35-40 (TAIWAN) . THIS STUDY AIMED TO COMPARE THE CLINICAL, RADIOLOGIC, AND COST-EFFECTIVENESS RESULTS BETWEEN CONVENTIONAL BUTTRESS OR DYNAMIC COMPRESSION PLATES AND LOCKING PLATES FOR TREATING DISPLACED DISTAL TIBIAL FRACTURES. FROM JULY 2003 TO FEBRUARY 2008, 57 CONSECUTIVE PATIENTS (17 WOMEN AND 35 MEN; MEAN AGE, 48.8 YEARS) WITH DISTAL METAPHYSEAL TIBIAL FRACTURES WERE TREATED WITH EITHER CONVENTIONAL BUTTRESS PLATES (N=28) OR A LOCKING COMPRESSION PLATE (LCP) (N=24). ALL PATIENTS RECEIVED ADEQUATE FOLLOW-UP FOR AT LEAST 12 MONTHS. THE MEAN FOLLOW-UP TIME WAS 25.6 MONTHS (RANGE, 12¿54 MONTHS) FOR THE CONVENTIONAL PLATE GROUP AND 31.6 MONTHS (RANGE, 12¿50 MONTHS) FOR THE LCP GROUP. THE FOLLOWING COMPLICATIONS WERE REPORTED: 1 PATIENT HAD A POST-OP INFECTION. RECEIVED SURGICAL DEBRIDEMENT AND INTRAVENOUS ANTIBIOTICS FOR 2 WEEKS AND UNDERWENT SURGERY TO REMOVE THE IMPLANTS AFTER BONE UNION WAS ACHIEVED. 1 PATIENT HAD DELAYED INFECTION. RECEIVED SURGICAL DEBRIDEMENT AND INTRAVENOUS ANTIBIOTICS FOR 2 WEEKS AND UNDERWENT SURGERY TO REMOVE THE IMPLANTS AFTER BONE UNION WAS ACHIEVED. 5 PATIENTS HAD FAIR RESULTS. THIS REPORT IS FOR AN UNKNOWN SYNTHES LCP CONSTRUCT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218431 UNK - CONSTRUCTS: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention