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

Model Number	PEDICLE SCREW KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a minimally invasive revision surgery due to an adjacent level fracture, the initial construct was to be removed and replaced.While attempting to remove the locking screws from the originally placed 10-screw construct, one of the screws proved difficult to extract.It was eventually discovered that the locking screw contained a broken set screwdriver tip.Despite this complication, the entire construct was successfully removed with considerable effort.The initial surgery, which was also performed minimally invasively, was supported on-site by a company representative.No irregularities were noted during the final fixation of the set screw at that time.It was reported this event didn't impact the patient outcome.Also, no patient pain related to implant was reported in between the initial surgery and the revision surgery.However, we learned that the revision surgery took longer than expected.
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 combination of mis-handling from surgeons not following the surgical technique resulting in a higher friction in the set-screwdriver that leads to a higher torque applied on the tip and, in few cases, the breakage of the tip.

• 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: 22666371
• Report Number: 3013546462-2025-00003
• Device Sequence Number: 14409135
• Product Code: NKB
• UDI-Device Identifier: 07640177821027
• UDI-Public: (01)07640177821027
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PEDICLE SCREW KIT
• Device Catalogue Number: SC-60-30-PE
• Device Lot Number: 2024066818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SC-60-30-PE
• Patient Sex: Male