BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COCR LOCKING CAP 4.5MM, SMALL STATURE, T25, BT

    MDR report key: 20130630 · Received September 3, 2024

    Report

    Report Number
    3012120772-2024-00063
    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
    10889981185640
    PMA / PMN Number
    K232566
    Removal / Correction Number
    3012120772/11082024/R000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOCKING CAP WAS FUNCTIONALLY TESTED WITH MATING PARTS AND FOUND TO MATE PROPERLY. UPON DISASSEMBLY IT WAS NOTED THAT THERE WAS DAMAGE TO THE HIGBEE CUT FEATURE AT THE LEAD-IN THREAD. THERE WAS ALSO DAMAGE OR MATERIAL MISSING FROM THE MAJOR DIAMETER OF THE SET SCREW THREADS. THIS FAILURE WAS ANALYZED UNDER A HEALTH HAZARD EVALUATION AND FOUND THE OBSERVED NON-CONFORMANCES REPRESENTED A MODERATE RISK OF ADVERSE HEALTH CONSEQUENCES. A FIELD ACTION WAS INITIATED TO RECALL THE AFFECTED LOTS OF PN 79-0002. REFER TO REPORT OF CORRECTIONS AND REMOVAL NUMBER 3012120772/11082024/R0001. THE FOLLOWING REPORTS ARE ALSO RELATED: 3012120772-2024-00079, 3012120772-2024-00080, 3012120772-2024-00081, 3012120772-2024-00082, 3012120772-2024-00083. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE RETURNED PARTS IS ONGOING. THE FOLLOWING REPORTS ARE ALSO RELATED: (B)(4). 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 8 UNITS OF PART 79-0002, LOT MM1003065E.

    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. (B)(4) UNITS OF PART 79-0002 AND (B)(4) UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 1 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833447 COCR LOCKING CAP 4.5MM, SMALL STATURE, T25, BT SCREW NKB SEASPINE ORTHOPEDICS CORPORATION 79-0002 MM1003065E 10889981185640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other