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

Model Number	41-3010
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 41-3010 mariner polyaxial head was returned and evaluated.Visual inspection revealed that multiple threads on the 41-3010 polyaxial head were deformed and collapsed into each other.In this condition,a set screw would not be able to thread onto the polyaxial head, confirming the reported failure.Root cause: review of the dhr confirmed that proximal thread specifications were in tolerance and that the functional check with the driver passed at inspection.The deformation observed on the leading threads of the polyaxial head is likely the result of the set screw being inserted off axis, resulting in cross-threading.Applied torque under these conditions would likely cause the identified thread deformation.However, the root cause of the deformation seen further down in the polyaxial head (below the thread profile) was unable to be determined based on the information provided.Intraoperative warnings breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
Event or Problem Description
On 10 apr 2026 seaspine/orthofix was made aware of a 30-minute surgical delay involving the mariner spinal system.Per the reporter, after the surgeon implanted a screw during an l3 pelvis case on (b)(6) 2026, he experienced issues threading the set screw onto the tulip.The surgeon attempted to resolve the issue using two different set screws, however, neither set screw would thread onto the tulip.The surgeon proceeded to remove the screw and tulip and replaced it with a new one.The case was able to be completed successfully and no patient injuries were reported.The issue resulted in a delay of approximately 30 minutes.

• Brand Name: MARINER
• 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: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008 ; 7607278399
• MDR Report Key: 25129353
• Report Number: 3012120772-2026-00027
• Device Sequence Number: 9322221
• Product Code: NKB
• UDI-Device Identifier: 10889981155117
• UDI-Public: 10889981155117
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/08/2026

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: 41-3010
• Device Catalogue Number: 41-3010
• Device Lot Number: AW199683G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MD1-100016 POINTLOCK SET SCREW, LOT: AW197304B; MD1-100016 POINTLOCK SET SCREW, LOT: DH34070C
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown