BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7481420 · Received May 2, 2018

    Report

    Report Number
    8030965-2018-53506
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    April 23, 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX OSTEOTOMY PLATE /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THE (510K): UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR TOMOFIX OSTEOTOMY PLATE IS NOT PROVIDED. 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. [(B)(4)].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: NIEMEYER P. ET AL, (2010) OPEN-WEDGE OSTEOTOMY USING AN INTERNAL PLATE FIXATOR IN PATIENTS WITH MEDIAL-COMPARTMENT GONARTHRITIS AND VARUS MALALIGNMENT: 3-YEAR RESULTS WITH REGARD TO PREOPERATIVE ARTHROSCOPIC AND RADIOGRAPHIC FINDINGS. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY. VOLUME 26. NUMBER 12. PAGES 1607-1616. (GERMANY). THIS PROSPECTIVE, OBSERVATIONAL, THERAPEUTIC CASE STUDY WAS DESIGNED TO EVALUATE CLINICAL RESULTS OF PATIENTS UNDERGOING OPEN-WEDGE HIGH TIBIAL OSTEOTOMY (HTO) AND STABILIZATION BY A MEDIAL PLATE FIXATOR FOR UNICOMPARTMENTAL OSTEOARTHRITIS OF THE KNEE WITH VARUS MALALIGNMENT. FROM APRIL 2004 TO JULY 2007, 69 PATIENTS WITH A MINIMUM FOLLOW-UP OF 36 MONTHS WHO UNDERWENT OPEN-WEDGE HTO FOR MEDIAL-COMPARTMENT OSTEOARTHRITIS OF THE KNEE WERE INCLUDED. THE MEAN PATIENT AGE WAS 46.73 +/- 9.99 YEARS. THERE WERE 13 FEMALES AND 56 MALES. TWENTY-ONE OF THESE PATIENTS ARE SMOKERS. IN ALL CASES, AN UNKNOWN SYNTHES TOMOFIX OSTEOTOMY SYSTEM WAS USED. ALL OPERATIONS WERE PERFORMED WITH THE PATIENTS UNDER GENERAL ANESTHESIA. COMPLAINTS WERE REPORTED AS FOLLOWS: INTRAOPERATIVELY, ONE PATIENT HAS INTRA-ARTICULAR FRACTURE OF THE LATERAL TIBIA PLATEAU THAT REQUIRED ADDITIONAL OSTEOSYNTHESIS. POSTOPERATIVELY, TWO PATIENTS HAVE DELAYED UNION, WHICH WERE TREATED WITH ADDITIONAL AUTOLOGOUS BONE GRAFT FROM THE ILIAC CREST. ONE PATIENT HAS DISTURBED POSTOPERATIVE WOUND HEALING. THREE PATIENTS HAVE CASES OF OVERCORRECTION (DEFINED AS POST POSTOPERATIVE WEIGHT-BEARING LINE >70% OF TRANSVERSE DIAMETER OF PROXIMAL TIBIA) IN WHICH REVISION SURGERY WAS RECOMMENDED TO THE PATIENTS AND WAS PERFORMED ON DAY 5 (OR DAY 6) IN ALL PATIENTS. TWENTY-EIGHT PATIENTS FELT THAT THE IMPLANT WAS UNCOMFORTABLE AND COMPLAINED ABOUT LOCAL IRRITATION ASSOCIATED WITH THE IMPLANT SUGGESTIVE OF THE IMPLANT DESIGN. IN ALL THESE CASES, IRRITATIONS DISAPPEARED AFTER IMPLANT REMOVAL UPON CONSOLIDATION OF THE OSTEOTOMY GAP. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX OSTEOTOMY PLATE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322825 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention