BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7532619 · Received May 22, 2018

    Report

    Report Number
    8030965-2018-53898
    Event Type
    Injury
    Date Received
    May 22, 2018
    Report Date
    May 4, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SYNTHES AO SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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: LOBENHOFFER, P. AND AGNESKIRCHNER, J. (2003) IMPROVEMENTS IN SURGICAL TECHNIQUE OF VALGUS HIGH TIBIAL OSTEOTOMY. KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY. VOLUME 11. PAGES 132-138. JANUARY 11, 2003. (GERMANY). THIS STUDY PRESENTS FOUR TECHNICAL MODIFICATIONS OF HIGH TIBIAL OSTEOTOMY FACILITATING CORRECT PERFORMANCE AND MINIMIZING COMPLICATIONS OF THIS PROCEDURE. BETWEEN MAY 1998 AND AUGUST 2002, A TOTAL OF 331 PATIENTS UNDERWENT VALGUS HIGH TIBIAL OSTEOTOMY, HTO, 227 OF WHOM WERE OPERATED ON USING THE OPEN WEDGE TECHNIQUE. 101 PATIENTS WERE TREATED WITH TECHNIQUE DEVELOPED FOR NON-SYNTHES SPACER PLATE. THE PLATE WITH INTEGRATED METAL SPACER WAS FIXED WITH FOUR AO SCREWS TO THE TIBIA TO HOLD THE OSTEOTOMY OPEN. IN THE NEXT SERIES, 112 CONSECUTIVE PATIENTS WERE TREATED WITH RIGID FIXATION INCLUDING OSTEOSYNTHESIS WITH AN UNKNOWN SYNTHES TOMOFIX PLATE-FIXATOR. EIGHT LOCKED BOLTS ARE USED IN THE TOMOFIX DEVICE, FOUR PROXIMAL AND FOUR DISTAL TO THE OSTEOTOMY. REHABILITATION WITH EARLY PARTIAL WEIGHT-BEARING FROM DAY 2 AND FULL WEIGHT-BEARING BETWEEN 6 AND 9 WEEKS AFTER SURGERY. COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE LATE INFECTION TREATED BY EARLY REMOVAL OF THE FIXATOR. ONE HAD OVERCORRECTION WHICH WAS REVISED BY REPOSITIONING THE DISTAL BOLTS OF THE FIXATOR. SOME PATIENTS HAD MINOR SYMPTOMS OVER THE PLATE, AND FOUR PLATES HAVE BEEN REMOVED. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SYNTHES AO SCREWS. THIS IS REPORT 2 OF 2 FOR PC-(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
    374603 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention