BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA

    MDR report key: 11398984 · Received March 2, 2021

    Report

    Report Number
    8030965-2021-01519
    Event Type
    Injury
    Date Received
    March 2, 2021
    Report Date
    February 8, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PFNA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SHIN W.C.,ET AL (2019) EFFECT OF A SYNTHETIC OSTEOCONDUCTIVE BONE GRAFT SUBSTITUTE WITH ZETA POTENTIAL CONTROL (GENEX®DS) IN THE TREATMENT OF INTERTROCHANTERIC FRACTURE: A SINGLE CENTER EXPERIENCE OF 115 CONSECUTIVE PROXIMAL FEMORAL NAIL ANTIROTATIONS,JOURNAL OF ORTHOPAEDIC SCIENCE VOLUME 2, PAGES 842-849 HTTPS://DOI.ORG/10.1016/J.JOS.2019.01.010. THIS STUDY AIMS TO IDENTIFY THE CLINICAL EFFECT OF THE APPLICATION OF GENEX®DS IN ELDERLY PATIENTS WITH INTERTROCHANTERIC FRACTURE TREATED USING PFNA. FROM MARCH 2014 TO OCTOBER 2017, 315 PATIENTS UNDERWENT SURGERIES FOR THE TREATMENT OF INTERTROCHANTERIC FRACTURES. 233 PATIENTS (65 MEN AND 168 WOMEN) WITH MAN AGE OF 80.0 YEARS (RANGE; 66-94 YEARS) WERE ENROLLED IN THE STUDY. PFNA WAS USED IN ALL PATIENTS ACCORDING TO THE MANUFACTURER'S INSTRUCTION. GENEX®DS WAS CONSECUTIVELY INJECTED IN 115 PATIENTS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: BONE UNION WAS ONLY CONFIRMED IN 227 PATIENTS . THE AVERAGE SLIDING DISTANCE AT 1, 3, AND 12 MONTHS WAS 5.4 MM, 8.2 MM, AND 9.1 MM IN THE GENEX®DS GROUP AND 7.7 MM, 10.8 MM, AND 12.4 MM IN THE NO GENEX®DS GROUP, RESPECTIVELY, AND SIGNIFICANT DIFFERENCES IN SLIDING DISTANCE AT 1, 3, AND 12 MONTHS WERE IDENTIFIED. THIS REPORT IS FOR AN UNKNOWN SYNTHES PFNA. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296500 UNK - CONSTRUCTS: PFNA ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention