BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES

    MDR report key: 11474515 · Received March 12, 2021

    Report

    Report Number
    8030965-2021-01912
    Event Type
    Injury
    Date Received
    March 12, 2021
    Report Date
    February 16, 2021
    Manufacturer
    SYNTHES 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4). 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: ADANI, R. ET AL (2008), FREE FIBULA FLAP FOR HUMERUS SEGMENTAL RECONSTRUCTION: REPORT ON 13 CASES, LA CHIRURGIA DEGLI ORGANI DI MOVIMENTO, VOL. 91 (XX), PAGES 2126, HTTPS://DOI.ORG/10.1007/S12306-007-0004-5 (ITALY). THE AIM OF THIS STUDY IS TO INVESTIGATE THE ROLE OF VASCULARISED FIBULA GRAFT FOR RECONSTRUCTING THE HUMERUS DIAPHYSEAL SHAFT. BETWEEN JANUARY 1994 TO DECEMBER 2004, A TOTAL OF 13 PATIENTS (10 MALE AND 3 FEMALE) WITH A MEAN AGE OF 37 (RANGE FROM 21 TO 62) YEARS UNDERWENT MICROSURGICAL RECONSTRUCTION OF THE HUMERUS DIAPHYSEAL SHAFT WITH FREE FIBULA. FIBULA FIXATION WAS CARRIED OUT WITH BRIDGING PLATES IN 11 CASES: DYNAMIC COMPRESSION PLATE (DCP) IN 4 PATIENTS AND LOCKING COMPRESSION PLATE (LCP) IN 3 PATIENTS. IN 4 CASES RECONSTRUCTION PLATES (UNKNOWN DEVICE) WERE USED. PATIENT 11 HAD A DCP PLATE PROXIMALLY AND A RECONSTRUCTION PLATE (UNKNOWN DEVICE) DISTALLY. IN PATIENT 13 BONE FIXATION WAS ACHIEVED ONLY WITH SCREWS (UNKNOWN) BOTH PROXIMALLY AND DISTALLY. ALL PATIENTS WERE CLINICALLY REVIEWED BETWEEN 120 DAYS AND 14 MONTHS AFTER SURGERY. THE MEAN FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PATIENT 3: A (B)(6) PATIENT DEVELOPED A FRACTURE TO THE FIBULAR SHAFT ASSOCIATED TO PLATE RUPTURE 10 MONTHS POSTOPERATIVELY, AFTER APPARENT CONSOLIDATION. IN THIS CASE SURGERY IMPLIED HARDWARE REMOVAL, NEW SYNTHESIS WITH AN LCP PLATE AND CANCELLOUS BONE GRAFTING. BONE HEALING WAS ACHIEVED AFTER 3 MONTHS. PATIENT 6: IN A (B)(6) PATIENT, A CANCELLOUS BONE GRAFT WAS PERFORMED AT THE DISTAL INTERFACE 5 MONTHS AFTER THE INITIAL SURGERY TO ACHIEVE FRACTURE CONSOLIDATION. PATIENT 8: IN A (B)(6) PATIENT, A CANCELLOUS BONE GRAFT WAS INSERTED AT THE DISTAL INTERFACE TOGETHER WITH PLATE REMOVAL AND NEW OSTEOSYNTHESIS TO ACHIEVE FRACTURE CONSOLIDATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES DCP PLATES. THIS IS REPORT 1 OF 3 FOR PC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366590 UNK - PLATES PLATE,FIXATION,BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention