BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI-CP COMPRESSION PLATE UNKNOWN

    MDR report key: 7421417 · Received April 11, 2018

    Report

    Report Number
    9615741-2018-00061
    Event Type
    Injury
    Date Received
    April 11, 2018
    Report Date
    March 26, 2018
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K093914
    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.

    Additional Manufacturer Narrative · 1

    AS NO PRODUCT, ID AND NO MANUFACTURING LOT NUMBER WAS PROVIDED TO INTEGRA, NO DHR REVIEW WAS PERFORMED. AS PRODUCTS WERE NOT RETURNED, NO FAILURE ANALYSIS WAS PERFORMED. AS EXPLAINED BY THE AUTHOR, THE UNI-CP COMPRESSION PLATE WAS PLACED DORSAL INSTEAD OF DORSOLATERAL LEADING TO ITS FAILURE AT 13 MONTHS POSTOPERATIVE. A PLATE THAT IS PLACED DORSAL IS EXPOSED TO SHEAR FORCES DUE TO THE UNIFORMLY TRANSMITTED FORCES BETWEEN THE TALUS AND NAVICULAR, SEEN IN MWS PATIENTS. SO, THE ROOT CAUSE IS A WRONG LOCATION OF THE IMPLANT.

    Description of Event or Problem · 1

    THE FOOT AND ANKLE INTERNATIONAL (2014) PUBLISHED ¿ISOLATED TALONAVICULAR FUSION WITH TENSION BAND FOR MULLER-WEISS SYNDROME¿. THE AIM OF THIS STUDY WAS TO REPORT THE MIDTERM CLINICAL AND RADIOGRAPHIC RESULTS OF THIS TECHNIQUE, WHICH APPLIES THE TENSION BAND PRINCIPLE ON ISOLATED TALONAVICULAR (TN) ARTHRODESIS TO TREAT MÜLLER-WEISS SYNDROME (MWS) PATIENTS. TEN PATIENTS WITH ADVANCED DEFORMITY OF MÜLLER-WEISS SYNDROME (MWS) WERE TREATED WITH ISOLATED TALONAVICULAR (TN) ARTHRODESIS USING THE TENSION BAND TECHNIQUE. ONE PATIENT EXPERIENCED CONTINUOUS PAIN DUE TO IMPLANT FAILURE AND THUS NEEDED A REVISION AFTER 13 MONTHS. THE UNI-CP COMPRESSION PLATE WAS PLACED DORSAL INSTEAD OF DORSOLATERAL LEADING TO ITS FAILURE AT 13 MONTHS POSTOPERATIVE. A PLATE THAT IS PLACED DORSAL IS EXPOSED TO SHEAR FORCES DUE TO THE UNIFORMLY TRANSMITTED FORCES BETWEEN THE TALUS AND NAVICULAR, SEEN IN MWS PATIENTS. IN THIS CASE FUSION OF THE TN JOINT WAS ACHIEVED AFTER 2 MONTHS BY REMOVING THE COMPRESSION PLATE AND ADDING 2 FURTHER SCREWS. FURTHER CONVALESCENCE WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263754 UNI-CP COMPRESSION PLATE UNKNOWN N/A HRS NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention