MAUDE Adverse Event Report: NEO MEDICAL SA NEO PEDICLE SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	PEDICLE SCREW KIT
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Production records from the involved lots have been checked and found no issues.Investigation is still ongoing, no unique root cause was identified.We believe the issue is a due to surgeon not following the surgical technique resulting lack of fixation of the set-screws in the initial implantation followed by loosening of the construct.The wrong handling might also be the cause of the breakage of the set-screwdriver tip.
Event or Problem Description
Breakage of a screwdriver tip, loosed stabilization necessitating revision two months after initial surgery.

• Brand Name: NEO PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NEO MEDICAL SA; route de lausanne 157a; villette, CH-10 96; SZ CH-1096
• Manufacturer (Section G): NEO MEDICAL S.A.; route de lausanne 157a; villette, CH-10 96; SZ CH-1096
• Manufacturer Contact: route de lausanne 157a; villette, CH-10-96
• MDR Report Key: 22675448
• Report Number: 3013546462-2025-00004
• Device Sequence Number: 9473278
• Product Code: NKB
• UDI-Device Identifier: 07640177820143
• UDI-Public: (01)07640177820143
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: K212489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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: PEDICLE SCREW KIT
• Device Catalogue Number: SC-70-55-PE
• Device Lot Number: 2024072128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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: Male