BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8605478 · Received May 13, 2019

    Report

    Report Number
    8030965-2019-63882
    Event Type
    Injury
    Date Received
    May 13, 2019
    Report Date
    April 15, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES 4.5/5.0 LOCKING COMPRESSION PLATES./UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR, MANUFACTURE DATE: 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: HUBER H, HAEFELI M, DIERAUER S, RAMSEIER L (2009). "TREATMENT OF REDUCED FEMORAL ANTETORSION BY SUBTROCHANTERIC ROTATIONAL OSTEOTOMY." ACTA ORTHOPAEDICA BELGICA. VOLUME 75. PAGE 490-496 (SWITZERLAND). THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE BONE HEALING AND COMPLICATION RATE AFTER SUBTROCHANTERIC ROTATIONAL OSTEOTOMY FIXED WITH THE ANGLE STABLE LOCKING COMPRESSION PLATE (LCP, SYNTHES), WITH FULL WEIGHT-BEARING ALLOWED POSTOPERATIVELY. BETWEEN JULY 2004 AND OCTOBER 2007, 25 PATIENTS (11 GIRLS, 14 BOYS) AGED BETWEEN 9 AND 18 YEARS (MEAN 13.0 YEARS) WITH REDUCED FEMORAL ANTETORSION WERE TREATED WITH A SUBTROCHANTERIC ROTATIONAL OSTEOTOMY. 4 PATIENTS WERE EXCLUDED FROM THE PRESENT STUDY DUE TO OTHER SIMULTANEOUS SURGERY PROHIBITING IMMEDIATE POSTOPERATIVE FULL WEIGHT BEARING. THEREFORE, 21 PATIENTS WITH A TOTAL OF 33 OSTEOTOMIES WERE INCLUDED IN THIS RETROSPECTIVE STUDY. ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES LOCKING COMPRESSION PLATE. FULL WEIGHT-BEARING WITH CRUTCHES WAS STARTED ON THE FIRST POSTOPERATIVE DAY IN MOST PATIENTS. FIRST CLINICAL AND RADIOGRAPHIC ASSESSMENT WAS MADE AFTER 6 WEEKS IN ALL BUT ONE PATIENT WHO HAD THE FIRST ASSESSMENT AFTER 8 WEEKS. IMPLANTS WERE REMOVED IN 17 OF THE 21 PATIENTS ABOUT 1 YEAR AFTER PRIMARY SURGERY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD NOT SHOWN COMPLETE BONE HEALING AFTER 6 WEEKS. THE PATIENT HAD A FOLLOW-UP RADIOGRAPH AFTER 7 MONTHS AND SHOWED COMPLETE CONSOLIDATION AT THAT TIME. 1 PATIENT HAD NOT SHOWN COMPLETE BONE HEALING AFTER 6 WEEKS. THE PATIENT HAD A FOLLOW-UP RADIOGRAPH AFTER 12 MONTHS AND SHOWED COMPLETE CONSOLIDATION AT THAT TIME. 2 PATIENTS HAD SIGNIFICANTLY LESS INGUINAL PAIN AFTER A FOLLOW-UP OF 6 TO 32 MONTHS. 2 PATIENTS HAD MINIMAL KNEE PAIN AFTER A FOLLOW-UP OF 11 TO 20 MONTHS. THIS REPORT IS FOR AN UNKNOWN SYNTHES 4.5/5.0 LOCKING COMPRESSION PLATES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398738 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention