BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION

    MDR report key: 11747279 · Received April 29, 2021

    Report

    Report Number
    3011421599-2021-00006
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    November 18, 2020
    Report Date
    April 26, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432027170
    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) 2019 WITH THE CROSSROADS MINIBUNION PRODUCTS LISTED ABOVE. X-RAY EVIDENCE IMMEDIATELY POST-OPERATION SHOWS THE PLATE NOT FULLY SEATED ONTO THE SHAFT OF THE 1ST METATARSAL AND A GAP AT THE OSTEOTOMY SITE. AT A 1-YEAR POST-OP FOLLOW UP VISIT, X-RAY EVIDENCE SHOWS A NON-UNION OF THE OSTEOTOMY AND A BROKEN NON-LOCKING SCREW .THE PATIENT IS VITAMIN D DEFICIENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO ADDRESS THE NON-UNION AND REMOVE ALL HARDWARE. NONE OF THE REPLACEMENT HARDWARE USED WERE CROSSROADS PRODUCTS. NO NON-CONFORMANCES WERE IDENTIFIED IN REVIEW OF MANUFACTURING RECORDS. POTENTIALLY, THE PLATE AND NON-LOCKING SCREW DID NOT HAVE ADEQUATE FIXATION INTRA-OPERATIVELY DUE TO THE PLATE NOT BEING SEATED COMPLETELY INTO POSITION IN THE METATARSAL SHAFT. MINIBUNION SCREWS WERE REMOVED IN ADDITION TO THE PLATE: REF: (B)(4), LN: 500740 QTY: 1 PRODUCT NAME: MINIBUNION 4.5MM OFFSET PLATE LONG. REF: (B)(4) , LN: 500726 QTY: 1 PRODUCT NAME: MINIBUNION LOCKING SCREW 3.0MM X 16MM. REF: (B)(4) , 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) 2019 WITH THE CROSSROADS MINIBUNION PRODUCTS LISTED ABOVE. X-RAY EVIDENCE IMMEDIATELY POST-OPERATION SHOWS THE PLATE NOT FULLY SEATED ONTO THE SHAFT OF THE 1ST METATARSAL AND A GAP AT THE OSTEOTOMY SITE. AT A 1-YEAR POST-OP FOLLOW UP VISIT, X-RAY EVIDENCE SHOWS A NON-UNION OF THE OSTEOTOMY AND A BROKEN NON-LOCKING SCREW .THE PATIENT IS VITAMIN D DEFICIENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO ADDRESS THE NON-UNION AND REMOVE ALL HARDWARE. NONE OF THE REPLACEMENT HARDWARE USED WERE CROSSROADS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645948 MINIBUNION PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 3100-0045 500740 00815432027170

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention