BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISC ORTHO SURGICAL INSTR

    MDR report key: 7639700 · Received June 26, 2018

    Report

    Report Number
    8030965-2018-54652
    Event Type
    Injury
    Date Received
    June 26, 2018
    Report Date
    June 4, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. THE 510K: THIS REPORT IS FOR AN UNKNOWN CERCLAGE PASSER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. 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).PDF].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TRIKHA V. ET AL (2018) ROLE OF PERCUTANEOUS CERCLAGE WIRE IN THE MANAGEMENT OF SUBTROCHANTERIC FRACTURES TREATED WITH INTRAMEDULLARY NAILS. CHINESE JOURNAL OF TRAUMATOLOGY. VOLUME 21, PAGES 42¿49 (INDIA). THIS RETROSPECTIVE STUDY WAS DONE TO ANALYZE THE CRITICAL ROLE OF MINIMALLY INVASIVE CERCLAGE WIRE APPLICATION IN DIFFICULT SUBTROCHANTERIC FRACTURES WITH PARTICULAR EMPHASIS ON CLINICO-RADIOLOGICAL OUTCOME AND COMPLICATIONS AS COMPARED TO FRACTURES MANAGED WITHOUT CERCLAGE WIRING. BETWEEN JANUARY 2012 TO JANUARY 2016, 61 PATIENTS WERE INITIALLY INCLUDED IN THE STUDY, HOWEVER 13 WERE LOST TO FOLLOW-UP, LEAVING 48 PATIENTS FOR THE FINAL ANALYSIS. TWENTY-ONE PATIENTS (9 MALES AND 12 FEMALES WITH A MEAN AGE OF 49.19 YEARS) WERE IMPLANTED WITH A CERCLAGE WIRE, UTILIZING AN UNKNOWN DEPUY SYNTHES PERCUTANEOUS CERCLAGE PASSER DEVICE AND THE OTHER 27 WERE NOT IMPLANTED WITH A CERCLAGE WIRE. ALL PATIENTS WERE CALLED TELEPHONICALLY OR BY LETTER FOR FINAL FOLLOW-UP EVALUATION IN THE OUTPATIENT DEPARTMENT. CLINICAL AND RADIOLOGICAL FOLLOW-UP WAS DONE FOR AN AVERAGE OF 20.8 MONTHS (RANGE 13-12 MONTHS). THE REPORTED COMPLICATION REPRESENTS THE PATIENTS WHO WERE IMPLANTED WITH AN UNKNOWN SYNTHES CERCLAGE WIRING. ONE PATIENT IN CERCLAGE GROUP DEMONSTRATED CLINICAL AND RADIOLOGIC SIGNS OF DELAYED-UNION; DYNAMIZATION OF NAIL WAS DONE AFTER 3 MONTHS, AND AFTER 6 MONTHS OF INDEX OPERATION, THIS PATIENT WAS FOUND TO HAVE UNION. ONE PATIENT HAD A LIMB LENGTH DISCREPANCY GREATER THAN 1 CM. ONE PATIENT SHOWED VARUS REDUCTION, ALBEIT, THAT PATIENT HAD UNEVENTFUL FRACTURE UNION. THIS REPORT IS FOR AN UNKNOWN SYNTHES PERCUTANEOUS CERCLAGE PASSER DEVICE. 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
    479732 MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention