BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION

    MDR report key: 11747271 · Received April 29, 2021

    Report

    Report Number
    3011421599-2021-00007
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    January 12, 2021
    Report Date
    April 27, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432027149
    PMA / PMN Number
    K190658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL BUNION CORRECTION WAS PERFORMED ON (B)(6) 2020 WITH THE CROSSROADS MINIBUNION PRODUCTS . X-RAY EVIDENCE AT 2-WEEKS POST-OPERATION SHOWS THE PLATE NOT FULLY SEATED ONTO THE SHAFT OF THE 1ST METATARSAL AND MINIMAL PURCHASE OF THE NON-LOCKING SCREW INTO THE LATERAL CORTEX OF THE SHAFT OF THE 1ST METATARSAL WITH THE SCREW HEAD SLIGHTLY BACKED OUT FROM THE PLATE. ACCORDING TO THE SURGEON, THE PATIENT HAD SEVERE POST-OPERATIVE SWELLING, EVIDENCE OF WOUND BREAKDOWN WITH INFECTION, AND A NON-LOCKING SCREW THAT BACKED-OUT POTENTIALLY FROM RESTLESS LEG SYNDROME. NON-CONFORMANCE WAS NOT IDENTIFIED BASED ON THE LOTS THAT WOULD CONTRIBUTE TO THESE EVENTS. SCREW BACK-OUT MAY HAVE BEEN DUE TO INADEQUATE FIXATION INTRA-OPERATIVELY OR DUE TO THE RESTLESS LEG SYNDROME OF THE PATIENT. THE FOLLOWING SCREWS WERE REMOVED WITH THE PLATE: REF: 3100-3024LK LN: 501198 QTY: 1 PRODUCT NAME: MINIBUNION LOCKING SCREW 3.0MM X 24MM. REF: 3100-2722NL LN: 500723 QTY: 1 PRODUCT NAME: MINIBUNION NON-LOCKING SCREW 2.7MM X 22MM.

    Description of Event or Problem · 1

    THE ORIGINAL BUNION CORRECTION WAS PERFORMED ON (B)(6) 2020 WITH THE CROSSROADS MINIBUNION PRODUCTS. X-RAY EVIDENCE AT 2-WEEKS POST-OPERATION SHOWS THE PLATE NOT FULLY SEATED ONTO THE SHAFT OF THE 1ST METATARSAL AND MINIMAL PURCHASE OF THE NON-LOCKING SCREW INTO THE LATERAL CORTEX OF THE SHAFT OF THE 1ST METATARSAL WITH THE SCREW HEAD SLIGHTLY BACKED OUT FROM THE PLATE. ACCORDING TO THE SURGEON, THE PATIENT HAD SEVERE POST-OPERATIVE SWELLING, EVIDENCE OF WOUND BREAKDOWN WITH INFECTION, AND A NON-LOCKING SCREW THAT BACKED-OUT POTENTIALLY FROM RESTLESS LEG SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645523 MINIBUNION PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 3100-0030 501230 00815432027149

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention