MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION STATIC PEEK CORPECTOMY 12MM SQ CAGE X 15MM LONG; SPACER

Model Number	15-10-1215
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery consisting of seaspine's vumesh vertebral body replacement system.X-rays taken the same day show that the cage's tantalum marker had migrated outside of the cage.Multiple attempts for additional information were made.No response was received.It is unknown if the cage remains implanted.No patient injury was reported.
Additional Manufacturer Narrative
The implant was not returned and therefore could not be evaluated.The reported failure was confirmed via the provided x-ray.No definitive root cause could be determined.Review of labeling: possible adverse events: 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 subsidence of the implant into adjacent bone.

• Brand Name: STATIC PEEK CORPECTOMY 12MM SQ CAGE X 15MM LONG
• Common Device Name: SPACER
• 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: 20135493
• Report Number: 3012120772-2024-00066
• Device Sequence Number: 7447044
• Product Code: MQP
• UDI-Device Identifier: 10889981036225
• UDI-Public: 10889981036225
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K070381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15-10-1215
• Device Catalogue Number: 15-10-1215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/04/2024
• 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