MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; 4.0MM VARIABLE ANGLE SCREW, SELF-DRILLING, 18MM

Model Number	AP1-714018
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected devices were not returned for evaluation.The lot numbers were not provided; therefore, a device history record review could not be performed.The postoperative imaging provided indicates that the one of the inferior-most screws (caudal screws) loosened/backed out as reported.Due to the absence of the returned device and lack of additional information, the specific root cause cannot be conclusively determined.No patient injury, revision surgery, or additional medical intervention has been reported.The reported event is consistent with known potential adverse events described in the device labeling.Review of labeling: 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.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.
Event or Problem Description
A patient underwent a 3 level acdf spinal surgery on (b)(6) 2025 consisting of the seaspine/orthofix admiral acp system.Seaspine/orthofix was made aware on (b)(6) 2026 that one of the inferior-most screws (caudal screws) backed out, approximately 6 months post-operatively.The part numbers that were reported were a ap1-714018 4.0mm variable angle screw and a ap1-310051 cervical plate, 3 level, 51mm.The reporter noted that the locking covers of the ap1-310051 cervical plate appeared to have been appropriately engaged at the completion of the index surgery.No patient injury was reported.Currently, the patient is being monitored by the surgeon and no revision surgery is planned.This report is being filed for the ap1-714018 4.0 mm variable angle screw.See 3012120772-2026-00006 report for the ap1-310051 cervical plate, 3 level, 51 mm.

• Brand Name: ADMIRAL
• Common Device Name: 4.0MM VARIABLE ANGLE SCREW, SELF-DRILLING, 18MM
• 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: 24499646
• Report Number: 3012120772-2026-00007
• Device Sequence Number: 15942651
• Product Code: KWQ
• UDI-Device Identifier: 10889981279103
• UDI-Public: 10889981279103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: AP1-714018
• Device Catalogue Number: AP1-714018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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