BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7590603 · Received June 12, 2018

    Report

    Report Number
    8030965-2018-54240
    Event Type
    Injury
    Date Received
    June 12, 2018
    Report Date
    May 17, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN PATIENT INFORMATION IS PROVIDED IN THE LITERATURE ARTICLE. THERE ARE MULTIPLE UNKNOWN DATES OF EVENT BETWEEN 2009 AND 2011. THIS REPORT IS FOR UNKNOWN TRAUMA SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THERE ARE MULTIPLE UNKNOWN DATES OF IMPLANTATION BETWEEN 2009 AND 2011. IT IS UNKNOWN IF OR WHEN DEVICES WERE EXPLANTED. COMPLAINANT PARTS ARE NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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, 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LEE, DH., PARK, S., PARK, H. AND HAN, SB (2016), EFFECT OF SOFT TISSUE LAXITY OF THE KNEE JOINT ON LIMB ALIGNMENT CORRECTION IN OPEN WEDGE HIGH TIBIAL OSTEOTOMY, KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY, VOL. 24, PAGES 3704-3712 (KOREA) THIS PROSPECTIVE STUDY ASSESSED THE RELATIONSHIP BETWEEN SOFT TISSUE LAXITY OF THE KNEE JOINT AND ALIGNMENT CORRECTION IN OPEN-WEDGE HIGH TIBIAL OSTEOTOMY (HTO). BETWEEN 2009 AND 2011, 85 PATIENTS (20 MALE AND 66 FEMALE) WITH MEAN AGE OF 57 (RANGE: 41-72) UNDERWENT NAVIGATION-ASSISTED OPEN-WEDGE HTO. THE OSTEOTOMY WAS STABILIZED USING A FIXED-ANGLE PLATE WITH INTERLOCKING SCREWS (TOMOFIX¿, SYNTHES, BETTLACH, SWITZERLAND OR SYNTHES GMBH, SOLOTHURN, SWITZERLAND). THE MECHANICAL AXIS (MA), WEIGHT-BEARING LINE (WBL) RATIO, AND JOINT LINE CONVERGENCE ANGLE (JLCA) WERE MEASURED ON RADIOGRAPHS PREOPERATIVELY AND AFTER 6 MONTHS, AND THE DIFFERENCES BETWEEN THE PRE-SURGERY AND POST-SURGERY. POST-OPERATIVE WBL RATIOS OF 57¿67 % WERE CLASSIFIED AS ACCEPTABLE CORRECTION. THE WBL RATIOS <57 AND >67 % WERE CLASSIFIED AS UNDER- AND OVERCORRECTIONS, RESPECTIVELY. ARTHRITIC CHANGES IN THE KNEE JOINT WERE EVALUATED USING KELLGREN¿LAWRENCE (KL) GRADES. THE FOLLOWING COMPLICATIONS WERE REPORTED: 20 KNEES HAD A POST-OPERATIVE WEIGHT BEARING LINE (WBL) RATIO <57% AND WERE CLASSIFIED AS UNDER-CORRECTED. 33 KNEES HAD A POST-OPERATIVE WBL RATIO >67% AND WERE CLASSIFIED AS OVER-CORRECTED. THIS REPORT IS FOR UNKNOWN TRAUMA SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435469 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention