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

Model Number	AP1-714018
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not available for evaluation; no lot information was provided.No definitive root cause could be established.Review of labeling: possible adverse events - 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
Customer reports an x-ray taken almost a year after surgery shows an admiral variable angle screw has backed out of what appears to be a locked plate.Although three follow-up attempts were performed, customer was unresponsive.No additional information was provided regarding this event.The product is not available for evaluation.

• 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: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 21277647
• Report Number: 3012120772-2025-00005
• Device Sequence Number: 21171085
• Product Code: KWQ
• UDI-Device Identifier: 10889981279103
• UDI-Public: 10889981279103
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/30/2025

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: AP1-714018
• Device Catalogue Number: AP1-714018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/30/2025
• 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