BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION

    MDR report key: 11730323 · Received April 27, 2021

    Report

    Report Number
    3011421599-2021-00008
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    December 30, 2020
    Report Date
    April 26, 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 · 0

    THE SURGEON REPORTS REMOVAL OF THE MINIBUNION DEVICE APPROXIMATELY 2 MONTHS POST-OPERATIVELY. THE (B)(6) FEMALE INITIALLY UNDERWENT DOUBLE OSTEOTOMY AND HALLUX VALGUS CORRECTION WITH PLACEMENT OF MINIBUNION FOR HALLUX VALGUS AND A STAPLE AT THE AKIN OSTEOTOMY. ADDITIONALLY, SOFT TISSUE ANCHORS WERE PLACED ACROSS THE DIP AND POP JOINTS OF THE 2ND AND 3RD TOE. THE PATIENT PRESENTED WITH SWELLING, REDNESS, AND SUPERFICIAL DRAINAGE AFTER ORAL ANTIBIOTICS. THE PLATE AND SCREWS (MINIBUNION) WERE REMOVED. THE MOTOCLIP REMAINS IMPLANTED. THE SURGEON NOTES THAT THE 1ST METATARSAL WAS STABLE. NO ADDITIONAL HARDWARE WAS PLACED IN THE 1ST METATARSAL. SWELLING AND IRRITATION RESOLVED AFTER HARDWARE REMOVAL. NO NON-CONFORMANCES WERE IDENTIFIED IN REVIEW OF MANUFACTURING RECORDS. MINIBUNION SCREWS WERE REMOVED IN ADDITION TO THE PLATE: REF: 3100-0030 LN: 501230 QTY: 1 PRODUCT NAME: MINIBUNION OFFSET. REF: 3100-3022LK LN: 501197 QTY: 1 PRODUCT NAME: 3.0MM X 22MM LOCKING SCREW. REF: 3100-2714NL LN: 501199 QTY: 1 PRODUCT NAME: 2.7MM X 14MM NON-LOCKING SCREW.

    Description of Event or Problem · 0

    THE SURGEON REPORTS REMOVAL OF THE MINIBUNION DEVICE APPROXIMATELY 2 MONTHS POST-OPERATIVELY. THE (B)(6) FEMALE INITIALLY UNDERWENT DOUBLE OSTEOTOMY AND HALLUX VALGUS CORRECTION WITH PLACEMENT OF MINIBUNION FOR HALLUX VALGUS AND A STAPLE AT THE AKIN OSTEOTOMY. ADDITIONALLY, SOFT TISSUE ANCHORS WERE PLACED ACROSS THE DIP AND POP JOINTS OF THE 2ND AND 3RD TOE. THE PATIENT PRESENTED WITH SWELLING, REDNESS, AND SUPERFICIAL DRAINAGE AFTER ORAL ANTIBIOTICS. THE PLATE AND SCREWS (MINIBUNION) WERE REMOVED. THE MOTOCLIP REMAINS IMPLANTED. THE SURGEON NOTES THAT THE 1ST METATARSAL WAS STABLE. NO ADDITIONAL HARDWARE WAS PLACED IN THE 1ST METATARSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626814 MINIBUNION PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 3100-0030 501230 00815432027149

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention