BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CMF

    MDR report key: 10207001 · Received June 29, 2020

    Report

    Report Number
    8030965-2020-04522
    Event Type
    Injury
    Date Received
    June 29, 2020
    Report Date
    June 15, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN CMF PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN (B)(6) 2010 TO (B)(6) 2018. 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. (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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MAZZOLA F, ET AL. (2020), TIME AND COST-ANALYSIS OF VIRTUAL SURGICAL PLANNING FOR HEAD AND NECK RECONSTRUCTION: A MATCHED PAIR ANALYSIS, ORAL ONCOLOGY, VOLUME 100, PAGES 1-7, (AUSTRALIA). THE AIM OF THIS STUDY IS TO PERFORM TIME AND COST-ANALYSIS OF A CASE-MATCHED SERIES OF PATIENTS TREATED WITH AND WITHOUT VIRTUAL SURGICAL PLANNING TECHNOLOGY BY A SINGLE RECONSTRUCTIVE SURGEON. BETWEEN JANUARY 2010 TO MARCH 2018, 138 PATIENTS WHO UNDERWENT OSSEOUS FREE FLAP RECONSTRUCTION OF THE MANDIBLE OR MAXILLA. THERE WERE 78 MALES AND 60 FEMALES WITH A MEDIAN AGE OF 62.5 YEARS (RANGE, 16-90 YEARS). THE PATIENTS WERE DIVIDED INTO 2 GROUPS ACCORDING TO THE RECONSTRUCTIVE APPROACH USED. THE FIRST GROUP (99 PATIENTS) RECEIVED A TRADITIONAL NON- VIRTUAL SURGICAL PLANNING APPROACH (NON-VSP GROUP), WHERE THE BONE GRAFT WAS CONTOURED ¿FREE-HAND¿ TO THE INTRA-OPERATIVE DEFECT. THE SECOND GROUP (29 PATIENTS) RECEIVED PROPRIETARY- VIRTUAL SURGICAL PLANNING (P-VSP GROUP) PROVIDED BY DEPUY SYNTHES, EACH-CASE INCLUDING A RECONSTRUCTIVE 3D-MODEL (SHOWING THE BONE GRAFT INSET TO THE FACIAL DEFECT), CUTTING GUIDES FOR THE DONOR AND ABLATIVE SITES, AND AN UNKNOWN SYNTHES TRUMATCH CUSTOMIZED TITANIUM PLATE WHICH IN EARLY CASES WAS MILLED TITANIUM WHILE IN MORE RECENT CASES WAS PRINTED TITANIUM. THE DATA COLLECTED FOR THE WHOLE POPULATION INCLUDED: DAYS REQUIRING INTENSIVE MONITORING WITH ONE TO ONE NURSING CARE EITHER IN A SPECIALIZED WARD OR INTENSIVE CARE UNIT (ICU), WARD LENGTH OF STAY (LOS), LENGTH OF PROCEDURE (CALCULATED FROM THE TIME THE PATIENT ENTERED THE ANESTHETIC BAY TO LEAVING THE OPERATING ROOM), POSTOPERATIVE COMPLICATIONS, NUMBER OF BONE SEGMENT USED FOR THE RECONSTRUCTION, NUMBER OF SCREWS, NUMBER AND TYPE OF PLATES USED (MINI-PLATE, RECONSTRUCTION PLATE OR PATIENT-SPECIFIC PLATE (PSP)), THE ABLATIVE SURGERY (E.G. SEGMENTAL MANDIBULECTOMY, TYPE OF NECK DISSECTION) AND DONOR SITE (FIBULA, SCAPULA OR ILIAC CREST). COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS RETURNED TO THE OPERATING ROOM, RESPECTIVELY FOR THE EVACUATION OF HEMATOMA AND A FISTULA. 1 PATIENT HAD WOUND DEHISCENCE TREATED CONSERVATIVELY WITH DRESSINGS. THIS REPORT IS FOR THE UNKNOWN SYNTHES TRUMATCH CUSTOMIZED TITANIUM PLATES AND SCREWS. THIS REPORT IS FOR ONE (1) UNKNOWN CMF PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670475 UNK - SCREWS: CMF PLATE, FIXATION ,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention