MAUDE Adverse Event Report: CARLSMED, INC APREVO TRANSFORAMINAL LUMBAR INTERBODY FUSION DEVICE; INTERVERTERBRAL BODY FUSION DEVICE

Model Number	H.L23.02
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 an event was reported by carlsmed's director of sales, (b)(4), regarding dr.(b)(6) case with lot code, 230504.Bk.01 performed on (b)(6) 2023.The case was planned with a single level l23 aprevo tlif-oblique (left sided approach).The date of the event was (b)(6) 2023.During the placement of the l23 tlif-o intervertebral body fusion device (referred to as the 'device' in this section), the device rotated medially towards the spinal cord.The corner edge of the device came into contact with the anatomy of the spinal cord, resulting in a dural tear.The tear required intervention, and the surgeon spent an additional 10-15 minutes to repair the dural tear.It was reported that the device was fully seated and threaded onto the instrument.According to the surgeon, the patient is in good condition with no reports of any long term symptoms.

• Brand Name: APREVO TRANSFORAMINAL LUMBAR INTERBODY FUSION DEVICE
• Common Device Name: INTERVERTERBRAL BODY FUSION DEVICE
• Manufacturer (Section D): CARLSMED, INC; 1800 aston ave; ste 100; carlsbad CA 92008
• Manufacturer (Section G): CARLSMED, INC; 1800 aston ave; ste 100; carlsbad CA 92008
• Manufacturer Contact: 1800 aston ave; ste 100; carlsbad, CA 98008 ; 7607661926
• MDR Report Key: 17286756
• Report Number: 3017936978-2023-00001
• Device Sequence Number: 15008580
• Product Code: MAX
• UDI-Device Identifier: 00810056990763
• UDI-Public: 00810056990763
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2023

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: 03/08/2024
• Device Model Number: H.L23.02
• Device Catalogue Number: H.L23.02
• Device Lot Number: 230504.BK.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2023
• 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 Age: 79 YR
• Patient Sex: Male