BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 8625255 · Received May 20, 2019

    Report

    Report Number
    8030965-2019-64201
    Event Type
    Injury
    Date Received
    May 20, 2019
    Report Date
    May 6, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN PLATES. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN PLATES. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: POUL, J., URBÁ¿EK, K., ROCÁK, K. (2013), EXACTNESS OF CORRECTION OF PROXIMAL FEMORAL DEFORMITIES USING CONVENTIONAL ANGLED BLADE PLATES AND THE CANNULATED PEDIATRIC OSTEOTOMY SYSTEM. COMPARISON OF TWO METHODS, ACTA CHIRURGIAE ORTHOPAEDICAE ET TRAUMATOLOGIAE CECHOSLOVACA, VOL. 80, PAGES 43-46 (CZECH REPUBLIC). THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE ACCURACY OF THE INTRODUCTION AND THE ACHIEVEMENT OF THE PLANNED CORRECTION USING CAPOS INSTRUMENTATION VERSUS THE CONVENTIONAL APPROACH. BETWEEN 1994 TO 2003, A TOTAL OF 42 PATIENTS (57 HIPS) WERE TREATED WITH AO ANGLED BLADE PLATE (90 DEGREES, 120 DEGREES, 130 DEGREES). BETWEEN 2004 TO 2012, A TOTAL OF 59 PATIENTS (68 HIPS) WERE TREATED BY THE CANNULATED PEDIATRIC ORTHOPEDIC SYSTEM (CAPOS) METHOD. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: FAILURE IN THE INFILTRATION OF THE TIP OF THE PLATE BLADE IN THE ANTERIOR OR POSTERIOR CORTICALIS OF THE FEMORAL NECK IN 6 HIPS IN AO GROUP (GRAPH 2). INCIDENCE OF ERROR IN PROXIMAL FEMORAL CORRECTION GREATER THAN 10° IN THE FRONTAL PLANE IN 12 HIPS IN AO GROUP (GRAPH 1). FAILURE IN THE FRONTAL PLANE OCCURRED IN 4 HIPS (GRAPH 3), AND IN 1 HIP IN THE ANTEROPOSTERIOR DIRECTION IN CAPOS GROUP (GRAPH 4). THE MOST COMMON ERRORS INCLUDED CASES IN WHICH THE PLATE BLADE WAS NOT INSERTED PRECISELY INTO THE CANAL CREATED BY THE INTRODUCTION CHISEL (3 CASES) AND THE GUIDE WIRE WAS NOT INSERTED IN OSTEOPOROTIC BONE PRECISELY ENOUGH (2 CASES). AT OTHER TIMES, THE DIRECTION OF THE INTRODUCTION CHISEL DEVIATED FROM THE GUIDE WIRE. THIS REPORT IS FOR UNKNOWN PLATES. IT CAPTURES THE REPORTED FAILURE IN THE INFILTRATION OF THE TIP OF PLATE BLADE IN 6 HIPS (AO). THIS IS REPORT 1 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419410 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention