BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOCKING CAP ASM. 4.5MM SMALL STATURE

    MDR report key: 20130651 · Received September 3, 2024

    Report

    Report Number
    3012120772-2024-00082
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 5, 2024
    Report Date
    November 26, 2024
    Manufacturer
    SEASPINE ORTHOPEDICS CORPORATION
    Product Code
    NKB
    UDI-DI
    10889981130619
    PMA / PMN Number
    K232566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE RETURNED PARTS IS ONGOING. THE FOLLOWING REPORTS ARE ALSO RELATED: 3012120772-2024-00078, 3012120772-2024-00079, 3012120772-2024-00080, 3012120772-2024-00081, 3012120772-2024-00083. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS.

    Additional Manufacturer Narrative · 0

    UPDATE TO B5: ADDITIONAL EVENT INFORMATION ADDED. (3 SHORELINE ACS PLATE LOCKING COVER, NO DELAY IN SURGERY, NO REVISION SURGERY PERFORMED) NO PART OR LOT NUMBERS WERE PROVIDED. NO FURTHER EVALUATION CAN BE COMPLETED. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS: BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS LOOSENING OF SPINAL FIXATION IMPLANTS MAY OCCUR DUE TO INADEQUATE INITIAL FIXATION, LATENT INFECTION, AND/OR PREMATURE LOADING, POSSIBLY RESULTING IN BONE EROSION, MIGRATION, OR PAIN.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 2 OF 3 UNITS OF PART 76-0030, LOT MD15297D.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 2 OF 3 UNITS OF PART 76-0030, LOT MD15297D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711246 TI LOCKING CAP ASM. 4.5MM SMALL STATURE SCREW NKB SEASPINE ORTHOPEDICS CORPORATION 76-0030 MD15297D 10889981130619

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other