MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MERIDIAN; NO-PROFILE LOCKING COVER

Model Number	RA1-250000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation as it remains implanted.No lot number was provided.A definitive root cause could not 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
On 18 jun 2025, seaspine/orthofix was made aware of ra1-250000 no-profile locking cover that had backed out of a waveform a no-profile cage construct.The issue was observed approximately three weeks after the index surgery.The exact date of implantation is unknown.The provided x-ray corroborates the report.No patient injury was reported, and no revision surgery is planned currently.

• Brand Name: MERIDIAN
• Common Device Name: NO-PROFILE 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 22438809
• Report Number: 3012120772-2025-00041
• Device Sequence Number: 4593481
• Product Code: OVD
• UDI-Device Identifier: 10889981215835
• UDI-Public: 10889981215835
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200879
• 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): 07/08/2025

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: RA1-250000
• Device Catalogue Number: RA1-250000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAVEFORM A NO-PROFILE CAGE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown