BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7611614 · Received June 18, 2018

    Report

    Report Number
    8030965-2018-54408
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    October 3, 2017
    Report Date
    May 29, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 156 PATIENTS (41 FEMALE AND 115 MALE) WERE INCLUDED IN THE STUDY AND WERE ALLOCATED INTO THREE DIFFERENT GROUPS ACCORDING TO THE DEGREE OF AXIS CORRECTION; (GROUP A 50¿55% WITH 39 PATIENTS, GROUP B 55¿60% WITH 50 PATIENTS, GROUP C > 60% WITH 67 PATIENTS). DATE OF EVENT IS UNKNOWN; (B)(6) 2017 IS WHEN THE LITERATURE ARTICLE WAS PUBLISHED. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: HOHLOCH ET AL (2017). CUSTOMIZED POST-OPERATIVE ALIGNMENT IMPROVES CLINICAL OUTCOME FOLLOWING MEDIAL OPEN-WEDGE OSTEOTOMY. KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY. (GERMANY). THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFECT OF THE SIZE OF AXIS CORRECTION ON FUNCTIONAL OUTCOME IN PATIENTS UNDERGOING A VALGUS HTO. FROM 2003 TO 2013, 205 PATIENTS WERE TREATED WITH A BIPLANAR VALGUS HTO, WHERE, 49 PATIENTS WERE LOST TO FOLLOW-UP, 18 OF WHICH WERE DUE TO UNDER-CORRECTION. A TOTAL OF 156 PATIENTS (41 FEMALE AND 115 MALE) WERE INCLUDED IN THE STUDY AND WERE ALLOCATED INTO THREE DIFFERENT GROUPS ACCORDING TO THE DEGREE OF AXIS CORRECTION; (GROUP A 50¿55% WITH 39 PATIENTS, GROUP B 55¿60% WITH 50 PATIENTS, GROUP C > 60% WITH 67 PATIENTS). ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES TOMOFIX FOR STABILIZATION OF THE BIPLANAR OSTEOTOMY. THE MEAN FOLLOW-UP PERIOD WAS 69 MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: FOUR PATIENTS HAD NON-UNION AND WERE REVISED. ONE PATIENT HAD POPLITEAL ANEURYSM AND WAS REVISED. TWO PATIENTS HAD OVERCORRECTION AND WERE REVISED. TWO PATIENTS HAD INFECTION AND WERE REVISED. FIVE PATIENTS HAD SUPERFICIAL WOUND INFECTION AND WERE REVISED. GROUP A HAS A POST-OP MEAN VAS OF 1.8 ± 1.4, POST-OP MEAN LYSHOLM SCORE OF 76.1 ± 18.4 AND POST OP MEAN KOOS OF 70.5 ± 19.0. GROUP B HAS A POST-OP MEAN VAS OF 2.7 ± 1.2 AND POST-OP MEAN LYSHOLM SCORE OF 68.2 ± 22.8 AND POST-OP MEAN KOOS OF 62.5 ± 19.8. GROUP C HAS A POST-OP MEAN VAS OF 3.3 ± 2.1 AND POST-OP MEAN LYSHOLM SCORE OF 65.6 ± 23.6 AND POST-OP MEAN KOOS OF 63.8 ± 21.8. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX PLATE. THIS REPORT IS 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453043 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention