BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: TOMOFIX OSTEOTOMY

    MDR report key: 10449218 · Received August 25, 2020

    Report

    Report Number
    8030965-2020-06278
    Event Type
    Injury
    Date Received
    August 25, 2020
    Report Date
    July 30, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS 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 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. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE:YANG J., ET AL (2018) CLINICAL EXPERIENCE USING A 3D-PRINTED PATIENT-SPECIFIC INSTRUMENT FOR MEDIAL OPENING WEDGE HIGH TIBIAL OSTEOTOMY, HINDAWI BIOMED RESEARCH INTERNATIONAL VOLUME XXXXXX, PAGES 1-9 (TAIWAN). THIS STUDY AIMS TO REPORT ON A NOVEL PSI GUIDE (DESIGNED BY A COMPANY SPECIALIZING IN THE PRODUCTION OF ORTHOPEDIC IMPLANTS, A PLUS BIOTECHNOLOGY CO. LTD., NEW TAIPEI CITY, TAIWAN) FOR PRECISE OSTEOTOMY AND ACCURATE DISTRACTION OF MEDIAL OPENING WEDGE HTO.EN PATIENTS (4 MALES AND 6 FEMALES) VOLUNTARILY ENROLLED IN THIS STUDY. THE AVERAGE AGE WAS 67.2 YEARS, RANGING FROM 56 TO 79 YEARS. TOMOFIX PLATE (TOMOFIX, SYNTHES (B)(4)) AND LOCKING SCREWS WERE USED TO FIX THE OSTEOTOMIZED TIBIA. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: THE FIRST PATIENT (NUMBER 1) WAS SEEN IN THE CLINIC THREE MONTHS POSTOPERATIVELY (FIGURE 6). HE STILL EXPERIENCED SOME PAIN AT THE MEDIAL JOINT LINE OF THE KNEE BUT WAS FULLY FUNCTIONAL. AT HIS ONE-YEAR FOLLOW-UP, THE MEDIAL JOINT LINE PAIN WAS NO LONGER PRESENT. HE STILL EXPERIENCED OCCASIONAL DISCOMFORT DUE TO THE PLATE BUT WAS VERY PLEASED WITH THE OUTCOME. FIGURE 7: PRE- AND POSTOPERATIVE COMPARISONS OF (A) THE WBL PERCENTAGE, WITH THE NEGATIVE VALUE INDICATING THAT THE WBL PASSES OUTSIDE MEDIALLY OF THE ENTIRE JOINT, AND (B) THE TIBIAL SLOPE. (THE PRE- AND POSTOPERATIVE RADIOGRAPHS OF TWO COMPARISON INDICES FOR THE FIRST PATIENT). THE NEGATIVE VALUES OF PREOPERATIVE WBL IN PATIENTS NUMBERS 4 AND 7 INDICATE THAT THE MECHANICAL AXIS IS LOCATED MEDIALLY TO THE MEDIAL TIBIAL PLATEAU. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911868 UNK - PLATES: TOMOFIX OSTEOTOMY PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention