BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA

    MDR report key: 9582776 · Received January 13, 2020

    Report

    Report Number
    8030965-2020-00313
    Event Type
    Injury
    Date Received
    January 13, 2020
    Report Date
    December 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PFNA/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. INVESTIGATION SUMMARY 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

    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: KIM, J.T. ET AL. (2019), SINGLE SCREW TYPE OF LAG SCREW RESULTS HIGHER REOPERATION RATE IN THE OSTEOSYNTHESIS OF BASICERVICAL HIP FRACTURE, JOURNAL OF ORTHOPAEDIC SCIENCE, S0949-2658(19)30059-4 (SOUTH KOREA). THE OBJECTIVE OF THIS MULTICENTER STUDY WAS TO ANALYZE THE SURGICAL OUTCOME OF BASICERVICAL HIP FRACTURES ACCORDING TO FIXATION TYPE OF PROXIMAL FEMUR AND SUBGROUP ANALYSIS OF CMN GROUP ACCORDING TO LAG SCREW TYPE. BETWEEN 2011 AND 2014, A TOTAL OF 106 PATIENTS WERE INCLUDED IN THE STUDY. 25 PATIENTS WERE TREATED WITH A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL (DEPUY SYNTHES, SOLOTHURN, SWITZERLAND). THE MEAN FOLLOW UP PERIOD WERE 2.2 (1.0-3.6) YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 15 PATIENTS DIED OR WAS LOST TO FOLLOWUP. A (B)(6) YEAR OLD FEMALE PATIENT HAD A GOOD FRACTURE REDUCTION STATUS AND HAD EXCESSIVE DISPLACEMENT AND OSTEONECROSIS TO THE FEMORAL HEAD. THIS REPORT IS FOR A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL (DEPUY SYNTHES, (B)(6). THIS IMPACTED PRODUCT CAPTURES THE REPORTED (B)(6) YEAR OLD FEMALE PATIENT HAD EXCESSIVE DISPLACEMENT AND OSTEONECROSIS TO THE FEMORAL HEAD. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45075 UNK - CONSTRUCTS: PFNA ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention