MAUDE Adverse Event Report: NEO MEDICAL NEO PEDICLE SCREW SYSTEM - ROD KIT PRE-BENT 90 MM (2X); THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	N.A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Event description: the surgeon (chu dijon) reported: "the case was simple, he did it with a surgical resident, there was no alert or special event, every-thing went fine.The reduction steps were respected: -tightening with the torque limiter all set-screws until everything is at the lowest position - then the last mm is tightened without the torque limiter - control x-ray is made before breaking and for controlling the reduction - final tightening with standard breakage of the 10n.M torque limiter of the set screw - no control of the stability of any set-screw was done at the end." the immediate post-op xray has been provided (rod is in the construct, chu dijon), and an x-ray after the problem occurred has been provided (rod detached and moved to buttock).Further the surgeon reported: "the rod moved down to the buttock.The patient underwent a new surgery for removal in another hospital." (the hospital where the removal was done was in private hospital (b)(6).Complaint investigation: the sales agent (lionel simon) have understood from interviewing the surgeons that "it seems that the patient took time to visit several surgeons in lyon, at least 2, before choosing, and it took about 2 months at least.So there was probably no hurry, so not so much pain".Neo medical checked the production records with the following conclusion: "no process deviations, specification violations or other anomalies were identified during manufacturing or final inspection.All components comply with the defined quality and release criteria." we got access to more intra-op imaging from the initial surgeon and checked this with a clinical expert, with vast experience in using neo pedicle screw system.The clinical expert opinion: we reviewed the intra-op x-rays send by the hospital where the initial operation took place.The x-rays show clearly that the tightening of the first rod was not performed correctly.To note is that one side of the construct was holding (which came from the same kits on the failed side), on one side there was no issue and it seems proper surgical technique has been used, which points towards wrong surgical technique has been used on the failed side.This is the first time neo medical has received a complaint of a complete disconnection of a rod postoperatively and a rod migration.More than 33000 surgeries have been performed with the neo pedicle screw system.Unfortunately we have not received the explanted screws, therefore we cannot check the connection, however we believe that the radiographs show clearly the most probable source of failed connection of one of the two rods.Therefore, neo medical conclude at this stage that the root cause for the migration of the rod is that the set screw was not tighten properly.Based on imaging it seems that not the proper surgical technique has been followed.

• Brand Name: NEO PEDICLE SCREW SYSTEM - ROD KIT PRE-BENT 90 MM (2X)
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NEO MEDICAL; route de lausanne 157a,; villette, 1096 ; SZ 1096
• Manufacturer (Section G): NEO MEDICAL; route de lausanne 157a,; villette, 1096 ; SZ 1096
• Manufacturer Contact: stefano adami ; route de lausanne 157a,; villette, 1096 ; SZ 1096
• MDR Report Key: 22300837
• Report Number: 3013546462-2025-00002
• Device Sequence Number: 12902214
• Product Code: NKB
• UDI-Device Identifier: 07640177820235
• UDI-Public: (01)07640177820235
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/20/2025

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: N.A
• Device Catalogue Number: RD-00-90-PB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SC-60-45-PESC-50-45-PE
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic