MAUDE Adverse Event Report: Spinal Elements, Inc Overwatch; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	108-SS
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury

• Brand Name: Overwatch
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): Spinal Elements, Inc; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer (Section G): Spinal Elements; 3115 melrose dr; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose dr; carlsbad, CA 92010 ; +1(160)607-1565
• MDR Report Key: 50242592
• Report Number: 3004893332-2026-00006
• Device Sequence Number: 13353729
• Product Code: NKB
• UDI-Device Identifier: 00840916131234
• UDI-Public: 00840916131234
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191576
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 108-SS
• 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: 08/07/2026
• Initial Report FDA Received Date: 08/13/2026
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male