BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOCKING CAP ASM. 4.5MM SMALL STATURE

    MDR report key: 20130652 · Received September 3, 2024

    Report

    Report Number
    3012120772-2024-00081
    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, 3012120772-2024-00082, 3012120772-2024-00083. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS.

    Additional Manufacturer Narrative · 0

    THE LOCKING CAP WAS FUNCTIONALLY TESTED WITH MATING PARTS AND FOUND TO NOT MATE PROPERLY. WHEN ADVANCING THE LOCKING CAP, THE LOCKING CAP COMPONENT BECAME STUCK AT THE PROXIMAL END OF THE SCREW HOUSING AND WAS NOT ABLE TO ADVANCE FURTHER. UPON DISASSEMBLY IT WAS NOTED THAT THE CAP HAD MINOR DAMAGE TO THE THREADS. A HEALTH HAZARD EVALUATION WAS INITIATED TO ANALYZE THIS FAILURE. IT WAS DETERMINED THAT ALTHOUGH THERE MAY BE INFORMATION TO SUGGEST A POTENTIAL NON-CONFORMANCE WITH PN 76-0030, THE NON-CONFORMANCE PRESENTS A NEGLIGIBLE RISK TO PATIENTS AS THE LOCKING CAP WOULD BE UNABLE TO APPROPRIATELY FIT WITH THE MATING PARTS. THIS WOULD RESULT WITH THE LOCKING CAPS BEING REPLACED INTRA-OPERATIVELY. PN 76-0030 IS NO LONGER BEING MANUFACTURED, THEREFORE NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. THE FOLLOWING REPORTS ARE ALSO RELATED: 3012120772-2024-00078, 3012120772-2024-00079, 3012120772-2024-00080, 3012120772-2024-00082, 3012120772-2024-00083. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS: BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS.

    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 1 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 1 OF 3 UNITS OF PART 76-0030, LOT MD15297D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711247 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