BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES

    MDR report key: 10567982 · Received September 22, 2020

    Report

    Report Number
    8030965-2020-07303
    Event Type
    Injury
    Date Received
    September 22, 2020
    Report Date
    September 7, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ROLLO G, ET AL. (2020), SURGICAL TREATMENT OF MULTIFRAGMENTARY SEGMENTAL FEMUR SHAFT FRACTURES WITH ORIF AND BONE GRAFT VERSUS MIPO: A PROSPECTIVE CONTROL-GROUP STUDY, MED GLAS (ZENICA), VOLUME 17 (2), PAGE 1-7, (ITALY). THE AIM OF THIS STUDY WAS TO COMPARE THE USE OF BIO METALLIC OPEN REDUCTION INTERNAL FIXATION (ORIF) (PLATE WITH ALLOGRAFT BONE STRUT) WITH MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) FIXATION FOR THE TREATMENT OF MULTI-SEGMENTAL FEMORAL SHAFT FRACTURE IN TERMS OF OUTCOMES, BONE HEALING AND COMPLICATIONS. FROM JANUARY 2016 TO DECEMBER 2019, 40 PATIENTS WITH SEGMENTAL FEMORAL SHAFT FRACTURES WERE INCLUDED IN THE STUDY AND DIVIDED INTO TWO GROUPS: 20 PATIENTS TREATED WITH ORIF+, 20 WITH MIPO. IN THE ORIF+ GROUP, THERE WERE 18 MALES AND 2 FEMALES WITH A MEAN AGE OF 39.67 YEARS (RANGE, 16-65 YEARS). THESE PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES 4.5-MM BROAD LOCKING COMPRESSION PLATE (LCP) SYSTEM OR THE UNKNOWN SYNTHES CONDYLAR PLATE LISS. 4 WERE IMPLANTED WITH A STRAIGHT LCP PLATE, 5 WITH A CURVED LCP PLATE, AND 11 WITH A CONDYLAR PLATE LISS. MEANWHILE, IN THE MIPO GROUP, THERE WERE 18 MALES AND 2 FEMALES WITH A MEAN AGE OF 39.56 YEARS (RANGE, 16-65 YEARS). THESE PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES 4.5-MM BROAD LOCKING COMPRESSION PLATE (LCP) SYSTEM OR THE UNKNOWN SYNTHES CONDYLAR PLATE LISS. 5 WERE IMPLANTED WITH A STRAIGHT LCP PLATE, 5 WITH A CURVED LCP PLATE, AND 10 WITH A CONDYLAR PLATE LISS. FROM THE POST-OPERATIVE UP TO THE THIRD WEEK ALL PATIENTS WORE A LONG LEG SPLINT PLASTER WITH A FLEXED KNEE AT 20 DEGREES. THE MEAN OF FOLLOW-UP WAS 18.36 (RANGE 12¿48) MONTHS FOR ORIF+ AND 18.48 (RANGE 12¿48) MONTHS FOR MIPO. COMPLICATIONS WERE REPORTED AS FOLLOWS: (MIPO GROUP) A (B)(6) YEAR OLD FEMALE PATIENT HAD THE PLATE AND SCREWS REMOVED AFTER 20 MONTHS FROM THE SURGERY AND THE PATIENT EXPERIENCED PAIN DURING WEIGHT-BEARING. AFTER 20 DAYS FROM ONSET OF SYMPTOMS, NO PAIN DURING WEIGHT-BEARING WAS EXPERIENCED AND THERE WAS RADIOLOGICAL PROOF OF DEFINITIVE BONE HEALING. (FIGURE 2). 2 PATIENTS HAD A BREAKAGE OF PLATES. THE TIME OF PLATE BREAKAGE WITH RESPECT TO SURGERY WAS: 110 DAYS IN ONE CASE AND 87 DAYS IN THE SECOND CASE. PATIENTS WERE REVISED USING LATERAL COMPRESSION LOCKING PLATE SCREWS AND MEDIAL ANTERIOR BONE STRUT ALLOGRAFT. ALL THESE SURGERIES WERE SUCCESSFULLY PERFORMED AND WERE UNEVENTFUL. A (B)(6) YEAR OLD PATIENT HAD PRESENTED LIMB SHORTENING AT 67 DAYS AFTER THE SURGERY AND THE RADIOGRAPHS SHOW THE BENDING EFFECT OF THE PLATE. THE PATIENT WAS REVISED USING LATERAL COMPRESSION LOCKING PLATE SCREWS AND MEDIAL ANTERIOR BONE STRUT ALLOGRAFT. THE SURGERY WAS SUCCESSFULLY PERFORMED AND WAS UNEVENTFUL. (FIGURE 3) THIS IS REPORT 2 OF 4 FOR (B)(4). THIS REPORT IS FOR THE UNKNOWN SYNTHES 4.5-MM BROAD LOCKING COMPRESSION PLATE (LCP) SYSTEM, UNKNOWN SYNTHES CONDYLAR PLATE LISS, AND UNKNOWN SYNTHES SCREWS. (PLATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033967 UNK - PLATES PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention