MAUDE Adverse Event Report: PRECISION SPINE, INC VAULT C ACDF SYSTEM; POSTERIOR CAGE

Model Number	37-CL-4206
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2026, by dr.(b)(6), utilizing the vault c acdf system.As the screws were about to be inserted, the anterior plate separated from the posterior cage.Upon inspection, a tine on the anterior place was found to be bent and unusable.The plate and cage were removed and replaced with other implants of the same size, readily available in the set.There was no patient injury any only minimal delay to the procedure.
Additional Manufacturer Narrative
D4 primary unique device identifier (udi) number - full udi number is not applicable as this device was manufactured prior to the initiation of udi numbers on the labeling.H1 type of reportable event - serious injury - although there was no serious injury associated with this event, it was assessed as a reportable serious injury due to medical intervention required to remove and replace the cage after the plate disassembled.H3 device evaluation - evaluation was not possible as the device has not been returned to date.Review of device history records found (b)(4) pieces of lot 4362ps released for distribution on 8/1/2014 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No conclusions can be drawn regarding the root cause of the reported disassembly.No corrective actions are recommended.Should the product be received a follow-up medwatch report will be filed upon completion of investigation.

• Brand Name: VAULT C ACDF SYSTEM
• Common Device Name: POSTERIOR CAGE
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 24653932
• Report Number: 3005739886-2026-00017
• Device Sequence Number: 20360926
• Product Code: OVE
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132029
• 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): 02/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 37-CL-4206
• Device Catalogue Number: 37-CL-4206
• Device Lot Number: 4362PS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2014
• 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: Required Intervention
• Patient Sex: Unknown