MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER DEFORMITY; UNI-PLANAR SCREW, 5.5MM X 35MM

Model Number	MD1-115535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 29 may 2026, orthofix became aware of an event involving a surgical procedure utilizing the mariner deformity system.It was reported that an md1-115535 uni-planar screw, 5.5mm x 35mm disassembled intra-operatively.The screw and its components were retrieved from the surgical site, however, according to the reporter this resulted in a surgical delay of 30 minutes.No patient injury, death, or additional medical or surgical intervention was reported.
Additional Manufacturer Narrative
The md1-115535 uni-planar screw, 5.5mm x 35mm was returned and evaluated by the engineer.The returned screw was visually inspected, and the failure mode was confirmed.The screw was completely disassembled.The disassembly can be attributed to the washer rotating out of its tab housing, as there was no deformation noted to any of the subcomponents.Possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: bending, disassembly, or fracture of implant and components.

• Brand Name: MARINER DEFORMITY
• Common Device Name: UNI-PLANAR SCREW, 5.5MM X 35MM
• 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: 25615769
• Report Number: 3012120772-2026-00032
• Device Sequence Number: 9102190
• Product Code: NKB
• UDI-Device Identifier: 10889981235758
• UDI-Public: 10889981235758
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K211606
• 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): 06/24/2026

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: MD1-115535
• Device Catalogue Number: MD1-115535
• Device Lot Number: AW170994K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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