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

Model Number	MD1-100016
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 08 dec 2025, seaspine/orthofix was made aware of a post-operative screw fracture related to the mariner mis posterior fixation spinal system.It was reported that a revision surgery was performed to correct the screw fracture.Neither the index surgery date nor the revision surgery date for the screw fracture were provided.(see mdr 3012120772-2025-00071 for this event).After the revision surgery, it was reported that a pointlock set screw backed out/loosened post-operatively, which required an additional revision surgery.This report is 1 of 2 being filed to document the post-operative set screw back out /loosening.See mdr 3012120772-2025-00073 for the second report related to this event.
Additional Manufacturer Narrative
Two md1-100016 pointlock set screws were returned along with the implants noted in d10 and are currently being evaluated by engineering.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components postoperative fracture due to trauma, defects, or poor bone stock.
Additional Manufacturer Narrative
The returned implants were evaluated by engineering.The returned set screw (lot: aw197296b) was visually inspected, and it was observed that the dimple on the screw was not imprinted.As the dimple was not imprinted, this indicates the set screw was not normalized to the rod, leading the rod to make contact with the lateral side of the set screw instead.Additionally, the threads of the returned set screw (lot: aw197296b) appear to have sheared.The set screw (lot: aw197296b) had an increased polished surface on its perimeter, potentially resulting in off-axis positioning and improper normalization in the assembly.If the rod is not perpendicular within the tulip and normalized to the set screw, the full fixation strength would not be achieved.This may cause off-axis loading with no dimple indentation and reduced thread engagement, leading to shearing once tightened.Insufficient fixation strength increases the likelihood of the set screw loosening under patient anatomical loading.(see 3012120772-2025-00073 for the evaluation of the set screw of lot: aw189566b).Review of labeling: possible adverse events: bending, disassembly, or fracture of implant and components.Postoperative fracture due to trauma, defects, or poor bone stock.

• Brand Name: MARINER
• Common Device Name: 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: robin quiusky ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 23945705
• Report Number: 3012120772-2025-00072
• Device Sequence Number: 13442820
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: AW197296B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 41-8545-2 CANNULATED SCREW 8.50 X 45MM.; MM1-000020 MIS POLYAXIAL HEAD.; MM1-156090 MIS PRECONTOURED ROD, 6.0 X 90MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown