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
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.
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 2 of 2 being filed to document the post-operative set screw back out /loosening.See mdr 3012120772-2025-00071 for the first report related to this event.
Event or Problem Description
This report is 2 of 2 being filed to document the post-operative set screw back out /loosening.See mdr 3012120772-2025-00072 for the first report related to this event.
Additional Manufacturer Narrative
B5: a correction was made to a sentence in the initial mdr submission.The returned implants were evaluated by engineering.The evaluation found no issues with the set screw of lot: aw189566b.The set screw of lot: aw189566b demonstrated intended normalization, as seen by the indentation on the dimple.(see 3012120772-2025-00072 for the evaluation of the set screw of lot aw197296b) 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: 23945701
• Report Number: 3012120772-2025-00073
• Device Sequence Number: 7845382
• 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: AW189566B
• 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: 02/28/2025
• 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