MAUDE Adverse Event Report: SeaSpine Orthopedics Corporation Shoreline ACS 85-4018 4.0mm Variable Screw, Self Tapping, 18mm

Model Number	85-4018
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury

• Brand Name: Shoreline ACS 85-4018 4.0mm Variable Screw, Self Tapping, 18mm
• Common Device Name: Screw
• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; +1(760)216-5655
• MDR Report Key: 50742615
• Report Number: 3012120772-2026-00047
• Device Sequence Number: 8541843
• Product Code: OVE
• UDI-Device Identifier: 10889981125363
• UDI-Public: 10889981125363
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 85-4018
• Device Catalogue Number: 85-4018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/11/2026
• 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: Required Intervention
• Patient Sex: Unknown