MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; CERVICAL PLATE, 1 LEVEL, 16MM

Model Number	AP1-110016
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ap1-110016 cervical plate, 1 level, 16mm is not available for evaluation as it was discarded by the customer.No definitive root cause could be established.Review of labeling: possible adverse events.Bending, disassembly, or fracture of implant and components.
Event or Problem Description
Customer reports that during a surgery that took place on (b)(6) 2025, the locking mechanism on the ap1-110016 cervical plate, 1 level, 16mm implant broke and would spin infinitely, rather than stopping after 90 degrees of rotation.All broken pieces were retrieved; however, the issue resulted in a 30-minute surgical delay.A backup was available and the surgery was able to complete.No additional medical or surgical treatment was required and there were no adverse patient outcomes.Customer states spd threw the ap1-110016 cervical plate, 1 level, 16mm implant away, therefore, the lot number was unable to be provided and the product will not be available for evaluation.

• Brand Name: ADMIRAL
• Common Device Name: CERVICAL PLATE, 1 LEVEL, 16MM
• 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
• MDR Report Key: 22161822
• Report Number: 3012120772-2025-00037
• Device Sequence Number: 20688411
• Product Code: KWQ
• UDI-Device Identifier: 10889981277970
• UDI-Public: 10889981277970
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• 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): 06/06/2025

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: AP1-110016
• Device Catalogue Number: AP1-110016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/06/2025
• 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