BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 7508655 · Received May 11, 2018

    Report

    Report Number
    8030965-2018-53715
    Event Type
    Injury
    Date Received
    May 11, 2018
    Report Date
    April 20, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN PATIENT INFORMATION IS CAPTURED IN THE LITERATURE ARTICLE. THERE ARE MULTIPLE UNKNOWN EVENT DATES BETWEEN (B)(6) 2012 AND (B)(6) 2015. THIS REPORT IS FOR UNKNOWN TITANIUM ELASTIC NAILS/UNKNOWN LOTS. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBERS ARE UNKNOWN. IMPLANTATION AND EXPLANTATION DATES ARE UNKNOWN. COMPLAINANT PART IS 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 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: SINGH, M., HALQA, S. AND CHIB, M. (2016) OUTCOME OF BICOLUMNAR FIXATION OF INTERCONDYLAR FEMUR FRACTURE WITH CONDYLAR BUTTRESS PLATE AND TENS (TITANIUM ELASTIC NAILS) NAIL. JK SCIENCE. VOLUME 18, NO. 3, PAGES 162-165. (INDIA). THIS PROSPECTIVE STUDY EVALUATES THE EFFICACY OF BOTH COLUMN FIXATIONS BY USING CONDYLAR BUTTRESS PLATE ON LATERAL SIDE AND THEN USING TITANIUM ELASTIC NAIL ON MEDIAL SIDE TO OBTAIN SUPPORT OF MEDIAL COLUMN AND PREVENT VARUS ANGULATION FROM JUNE 2012 TO JULY 2015. 53 PATIENTS (37 MALES AND 16 FEMALES AGED 23-56 YEARS) WITH COMMINUTED INTERCONDYLAR FRACTURE OF FEMUR WERE OPERATED. ONCE CONDYLAR FRAGMENTS WERE REDUCED, AN UNKNOWN SYNTHES TITANIUM BUTTRESS LOCKING PLATE WAS FIXED ON LATERAL SIDE. TWO SCREWS WERE INSERTED DISTALLY AND ONLY ONE SCREW PROXIMALLY. AN UNKNOWN SYNTHES TITANIUM ELASTIC NAIL WAS THEN FIXED FROM THE MEDIAL SIDE. FOLLOW UP AT THREE MONTHS TO ONE YEAR AFTER SURGERY. COMPLICATIONS WERE REPORTED AS FOLLOWS: COMPLICATIONS INCLUDE SUPERFICIAL WOUND INFECTION IN FIVE PATIENTS, MINIMAL PAIN IN TEN, KNEE STIFFNESS IN FOUR AND VARUS ANGULATION LESS THAN 5 DEGREE IN SEVEN PATIENTS. THE RESULT WAS POOR IN FOUR PATIENTS ACCORDING TO SCHATZKER AND LAMBERT SCORING SYSTEM. THIS REPORT IS FOR AN UNKNOWN SYNTHES TITANIUM BUTTRESS LOCKING PLATE, UNKNOWN SYNTHES SCREWS, AND UNKNOWN SYNTHES TITANIUM ELASTIC NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349044 ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention