MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER; POINTLOCK SET SCREW

Model Number	MD1-100016
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The set screw was returned and visually inspected to confirm the failure mode outlined in the description of the complaint.The set screw threads were sheared in a vertical direction, indicating that the set screw was cross-threaded.It cannot be confirmed when or how this occurred.Intraoperative warnings: breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.Implants and components should not be bent, reshaped, contoured, or otherwise modified.Use great care to ensure that the implant surfaces are not scratched or notched.
Event or Problem Description
On 23 mar 2026, seaspine/orthofix was made aware of a 45-minute surgical delay involving the mariner deformity spinal system.Per the reporter, the surgeon had trouble seating the final left l4 set screw into a uniplanar extended tab screw.Additionally, the reducers could not reduce the rod fully and disconnected from the tulip.Ultimately the screw and set screw were removed and replaced and the case was successfully completed.This report is for the associated set screw.

• Brand Name: MARINER
• Common Device Name: POINTLOCK SET SCREW
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 24879228
• Report Number: 3012120772-2026-00023
• Device Sequence Number: 13269136
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K212692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MD1-100016
• Device Catalogue Number: MD1-100016
• Device Lot Number: DH34070C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown