MAUDE Adverse Event Report: SurGenTec, LLC ION 55; System, Facet Screw Spinal Device

Model Number	SR17-1355 Rev B
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It appears that upon disengagement of the driver from the screw all seemed well.According to the physician, upon removing the cannula/drill-guide, the screw got sucked into the canal beneath the lamina.The physician had to do an emergent laminectomy at c/3 to remove the screw from the canal.Pt had issues, ct was ordered.All looked good and the patient is slowly improving.No surgentec devices malfunctioned during this procedure.

• Brand Name: ION 55
• Common Device Name: System, Facet Screw Spinal Device
• Manufacturer (Section D): SurGenTec, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer (Section G): SurGenTec, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer Contact: guilherme pires ; 911 clint moore rd; boca raton, FL 33487 ; +1(561)990-7882
• MDR Report Key: 50065953
• Report Number: 3012495575-2026-00003
• Device Sequence Number: 10207029
• Product Code: MRW
• UDI-Device Identifier: 00810131881801
• UDI-Public: 00810131881801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K251714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: SR17-1355 Rev B
• Device Catalogue Number: TI-K-55
• Device Lot Number: 2604005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown