MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS, INC. INTRACEPT ACCESS INSTRUMENTS; PROBE, RADIOFREQUENCY LESION AND ACCESSORIES

Model Number	FG 0060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Spinal Column Injury (2081); Vertebral Fracture (4520)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a l5 compression fracture 69 days post-op.Patient was subsequently treated with a l5 vertebroplasty/no teriparatide.Intracept treatment occurred on l2-s1, 5 levels.

• Brand Name: INTRACEPT ACCESS INSTRUMENTS
• Common Device Name: PROBE, RADIOFREQUENCY LESION AND ACCESSORIES
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way; suite 200; sunnyvale CA 94085 4068
• Manufacturer Contact: thomas slater ; 1230 midas way; suite 200; sunnyvale, CA 94085-4068 ; 6503681000
• MDR Report Key: 14740035
• Report Number: 3006789852-2022-00005
• Device Sequence Number: 19386764
• Product Code: GXI
• UDI-Device Identifier: 00852454006189
• UDI-Public: (01)00852454006189(17)230412(10)127310221
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2022

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 Expiration Date: 04/12/2023
• Device Model Number: FG 0060
• Device Catalogue Number: RLV AK05
• Device Lot Number: 127310221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 06/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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: Disability; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown