BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANTANAIL DEVICE - UNSPECIFIED

    MDR report key: 7229513 · Received January 30, 2018

    Report

    Report Number
    9615741-2018-00013
    Event Type
    Injury
    Date Received
    January 30, 2018
    Report Date
    January 5, 2018
    Manufacturer
    NEWDEAL SAS
    Product Code
    HSB
    PMA / PMN Number
    K091788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. OTHER MGF REPORT NUMBERS: 9615741-2018-00005, 9615741-2018-00004, 9615741-2018-00006, 9615741-2018-00012, 9615741-2018-00014.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON (B)(6) 2018. AS THE ISSUE IS NOT LINKED TO THE DESIGN OF THE PRODUCT, NO DHR, DESIGN SPECIFICATION OR DESIGN CHANGE RECORD WILL BE PERFORMED. A REVIEW OF THE CURRENT INSTRUCTION FOR USE WAS PERFORMED. IN CONCLUSION, PREOPERATIVE RISK FACTORS OF THIS GROUP ARE MENTIONED IN IFU AND COULD EXPLAIN DELAYED HEALING AND THUS REVISION SURGERY. ALSO, SINCE THE ISSUE IS NOT LINKED TO THE PRODUCT, NO FAILURE ANALYSIS WILL BE PERFORMED. THE ROOT CAUSE IS NOT CLEARLY DETERMINED BUT, PHYSICAL CONDITION, PREOPERATIVE RISK FACTORS AND ETIOLOGIES OF THE PATIENTS MIGHT BE REASON OF DELAYED UNION.

    Description of Event or Problem · 1

    5 OF 6 REPORTS: THE JOURNAL OF FOOT & ANKLE SURGERY (2018) PUBLISHED ¿EVALUATION OF MIDTERM RESULTS OF THE PANTA NAIL:AN ACTIVE COMPRESSION TIBIOTALOCALCANEAL ARTHRODESIS DEVICE¿. THIS STUDY RETROSPECTIVELY IDENTIFIED 19 PATIENTS RECEIVING THE PANTA NAIL DURING A 4-YEAR PERIOD, 6 OF THE PATIENTS EXPERIENCED DELAY UNION REQUIRING REVISION SURGERY THAT CONSISTED OF THE REMOVAL OF THE PROXIMAL LOCKING SCREWS OR A BONE GRAFTING PROCEDURE TO YIELD A SUCCESSFUL OUTCOME AT THE JOINTS IN WHICH ARTHRODESIS HAD BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72389 PANTANAIL DEVICE - UNSPECIFIED PANTA NAIL HSB NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention