MAUDE Adverse Event Report: SeaSpine Orthopedics Corporation Reef TA; TA Removal Tool

Model Number	TA2-005002
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury

• Brand Name: Reef TA
• Common Device Name: TA Removal Tool
• 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 ; +1(760)216-5150
• MDR Report Key: 50722602
• Report Number: 3012120772-2026-00045
• Device Sequence Number: 12977225
• Product Code: LXH
• UDI-Device Identifier: 10889981318406
• UDI-Public: 10889981318406
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 09/10/2026

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: TA2-005002
• Device Catalogue Number: TA2-005002
• Device Lot Number: WT36656A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown