MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MERIDIAN; MODULAR PLATE COMPRESSOR, SHORT

Model Number	RA2-006014
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device was returned to the manufacturer and received on 08 may 2026 for evaluation.Investigation is in progress.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
On (b)(6) 2026, during a spinal fusion procedure, the reporter experienced difficulty using a modular plate compressor to secure a plate to an implant.Multiple attempts were made using additional implants and plates; however, the condition persisted.An alternate instrument from a different instrument set was obtained and successfully used to complete the procedure.The event reportedly resulted in an approximate 30-minute surgical delay, prompting this report.The procedure was completed successfully with no reported patient injury or adverse clinical outcome.

• Brand Name: MERIDIAN
• Common Device Name: MODULAR PLATE COMPRESSOR, SHORT
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 25394810
• Report Number: 3012120772-2026-00030
• Device Sequence Number: 10671917
• Product Code: LXH
• UDI-Device Identifier: 10889981284503
• UDI-Public: 10889981284503
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: RA2-006014
• Device Catalogue Number: RA2-006014
• Device Lot Number: AL666437B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2022
• 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