MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER DEFORMITY; POLYAXIAL HEAD

Model Number	MM1-000020
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mm1-000020 mis polyaxial head was returned for analysis and is currently being evaluation by product development.Review of qf-10-01-99 mariner system ifu possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis), bending, disassembly, or fracture of implant and components, loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain pain, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin subsidence of the implant into adjacent bone loss of proper spinal curvature, correction, height, and/or reduction increased biomechanical stress on adjacent levels improper surgical placement of the implant causing stress shielding of the graft or fusion mass intraoperative fracture or perforation of the spine postoperative fracture due to trauma, defects, or poor bone stock serious complications associated with any surgery may occur.
Event or Problem Description
Seaspine/orthofix became aware on 28-oct-2025 that during final tightening of the construct, the surgeon reported difficulty achieving final torque on the left s1 set screw.After successfully tightening the right s1 screw, the surgeon attempted to final tighten the left s1 set screw; however, the set screw repeatedly "popped" and continued to turn without the torque handle clicking.The surgeon removed the rod, replaced the s1 screw on the left side, reinserted the rod, and used a new set screw to complete the construct.This resulted in an estimated surgical delay of approximately 20-30 minutes, prompting this report.The procedure was completed successfully and no patient injury occurred.This report is being submitted for the mm1-000020 mis polyaxial head.
Additional Manufacturer Narrative
Visual inspection of the returned device confirmed shearing of the threads at the tulip of the mm1-000020 implant.The reported failure mode was confirmed as thread damage.Based on the observed damage and the information provided regarding the intraoperative occurrence, elevated loading on the construct may have been present at the time of final tightening.If the rod was not fully seated within the tulip prior to final tightening, increased forces may have been transferred to the tulip threads during application of torque.Under such conditions, the presence of elevated loads may have contributed to shearing of the threads.Review of qf-10-01-99 mariner system ifu possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis), bending, disassembly, or fracture of implant and components, loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain pain, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin subsidence of the implant into adjacent bone loss of proper spinal curvature, correction, height, and/or reduction increased biomechanical stress on adjacent levels improper surgical placement of the implant causing stress shielding of the graft or fusion mass intraoperative fracture or perforation of the spine postoperative fracture due to trauma, defects, or poor bone stock serious complications associated with any surgery may occur.

• Brand Name: MARINER DEFORMITY
• Common Device Name: POLYAXIAL HEAD
• 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: 23646594
• Report Number: 3012120772-2025-00064
• Device Sequence Number: 4823253
• Product Code: NKB
• UDI-Device Identifier: 10889981177805
• UDI-Public: 10889981177805
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191648
• 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): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MM1-000020
• Device Catalogue Number: MM1-000020
• Device Lot Number: TE212853F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown