BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERCLAGE, FIXATION

    MDR report key: 7635080 · Received June 25, 2018

    Report

    Report Number
    8030965-2018-54598
    Event Type
    Injury
    Date Received
    June 25, 2018
    Report Date
    May 31, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDED IN THE LITERATURE ARTICLE. THERE ARE MULTIPLE UNKNOWN DATES OF EVENT SUBSEQUENT TO (B)(6) 2010. THE 510K: THIS REPORT IS FOR AN UNKNOWN AO CERCLAGE WIRE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THERE ARE MULTIPLE UNKNOWN DATES OF IMPLANTATION BETWEEN JANUARY 2010 TO DECEMBER 2015. IT IS UNKNOWN IF OR WHEN DEVICES WERE EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER IS UNKNOWN. 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).PDF]

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KULKARNI S.G. ET AL (2017) AUGMENTATION OF INTRAMEDULLARY NAILING IN UNSTABLE INTERTROCHANTERIC FRACTURES USING CERCLAGE WIRE AND LAG SCREWS: A COMPARATIVE STUDY. INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED. VOLUME 48, PAGES 18¿22 (INDIA). THE STUDY PRESENTS A TECHNIQUE OF LATERAL WALL AND TROCHANTERIC RECONSTRUCTION USING CERCLAGE WIRES AND LAG SCREWS IN THE GREATER TROCHANTER TO AUGMENT THE FIXATION OF THE INTRAMEDULLARY NAILING (IMN) FOR UNSTABLE FRACTURES, AND COMPARE THE RADIOLOGICAL AND FUNCTIONAL OUTCOMES WITH THE CASES IN WHICH IMN WAS USED WITHOUT AUGMENTATION. FROM JANUARY 2010 TO DECEMBER 2015, 154 PATIENTS (WITH A MEAN AGE OF 74 YEARS) WITH AN UNSTABLE FRACTURE OF THE PROXIMAL FEMUR WERE INCLUDED IN THE FINAL ANALYSIS. THESE PATIENTS WERE RANDOMLY DISTRIBUTED INTO TWO GROUPS, NAMELY: GROUP A WITH ADDITIONAL AUGMENTATION OF THE IMN FIXATION USING UNKNOWN SYNTHES CERCLAGE WIRE OR A LAG SCREW AND GROUP B WITH NO AUGMENTATION DONE IN ADDITION TO THE IMN AND DEROTATION SCREW. POST-OPERATIVE ANTIBIOTICS WERE GIVEN FOR 24¿48 HOURS AS PER PROTOCOL. FOLLOW-UP PERIOD WERE DONE AT 1.5, 3, 6 MONTHS, AND 1 YEAR RESPECTIVELY. THE POST-OPERATIVE STATUS WAS DETERMINED BY HARRIS HIP SCORE CALCULATED AT END OF 1-YEAR FOLLOW-UP. THE OUTCOME WAS CLASSIFIED AS POOR IF <70, FAIR IF 70¿79, GOOD IF 80¿89 AND EXCELLENT WHEN MORE THAN 90. THE FOLLOWING COMPLICATIONS ARE RELATED TO THE PATIENTS UNDER GROUP A WHO WERE IMPLANTED WITH AN UNKNOWN SYNTHES AO CERCLAGE WIRES: FIVE PATIENTS DIED WITHIN 2 MONTHS AFTER SURGERY DUE TO UNRELATED CO-MORBIDITIES AND 2 PATIENTS DIED WITHIN ONE YEAR POST-OP. (THE ARTICLE DOES NOT MENTION IF THE AO CERCLAGE WIRE OR ANY SYNTHES DEVICE WERE INVOLVED IN ALL THE REPORTED DEATH CASES). FOURTEEN PATIENTS HAD POOR OUTCOME ACCORDING TO THE HARRIS HIP SCORE. FIVE PATIENTS WERE NOTED TO HAVE DEVELOPED VARUS DEFORMITY WITH NO CLINICAL SYMPTOMS. THIS REPORT IS FOR AN UNKNOWN SYNTHES AO CERCLAGE WIRE. THIS REPORT IS 1 OF 1 FOR (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
    476440 CERCLAGE, FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention