MAUDE Adverse Event Report: SeaSpine Orthopedics Corporation Shoreline ACS; 7mm, Locking Cover

Model Number	85-2107
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury

• Brand Name: Shoreline ACS
• Common Device Name: 7mm, Locking Cover
• 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: 50846941
• Report Number: 3012120772-2026-00049
• Device Sequence Number: 21320554
• Product Code: OVE
• UDI-Device Identifier: 10889981125080
• UDI-Public: 10889981125080
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 85-2107
• Device Catalogue Number: 85-2107
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• 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