MAUDE Adverse Event Report: NEO MEDICAL SA NEO PEDICLE SCREW SYSTEM - ROD KIT PRE-BENT 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	ROD KIT PRE-BENT 40MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event description: set screw loosening and rod slippage (disconnection between the tulip and the rod) occurred a few weeks post op (original post op above and 3 week post op below) on one side of a l2/l3 llif fusion with posterior fixation.After review, it is expected that the rod used for the segment was 5mm too short.Complaint investigation: neo medical gathered the following information by interviewing surgeons and sales rep: "a too short rod was used".This type of issue is known and displayed in the surgical techniqe with a few mm overhang is described.By analysing the mri and x-rays images we can conclude that from measuring the overhang a 0.5mm difference on one side of the rod caused one side to slip (1.5mm overhang) while the other side did not (2.0 mm overhang).Neo medical also looked at the batch production records for the affected lots, the report concluded no relevant deviations related to product quality.The most probable root cause of the failure was that the rod used was too short resulting due to a lack of contact point between rod and screw head ("the tulip") resulting in a disconnection of the construct.This is the first time that a too short rod have been used in surgery, with more than 26000 surgeries performed to date, it gives an occurence of (b)(4).

• Brand Name: NEO PEDICLE SCREW SYSTEM - ROD KIT PRE-BENT 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NEO MEDICAL SA; rte de lausanne 157a,; villette, 1096 ; SZ 1096
• Manufacturer Contact: jonas larsson ; route de lausanne 157a; villette 1096 ; SZ 1096
• MDR Report Key: 21758861
• Report Number: 3013546462-2025-00001
• Device Sequence Number: 21012701
• Product Code: NKB
• UDI-Device Identifier: 07640177820181
• UDI-Public: 07640177820181
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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
• Device Model Number: ROD KIT PRE-BENT 40MM
• Device Catalogue Number: RD-00-40-PB
• Device Lot Number: 2021041973
• 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: 03/05/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2021
• 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-70-45-PE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic