MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM PEDICLE SCREW SYSTEM

Model Number	39-PA-8570
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the reform pedicle screw system.Surgeon noted the one of the screws was incorrectly position and during attempts to remove it, the tip of the retention bone-screwdriver (39-sp-0601) broke.A small rod was inserted into the screw and the entire screw was successfully removed using a strong rod holder.The surgeon then attempted to reposition and reinsert the same screw.However, it remained incorrectly placed and required removal.During the removal attempt the head of the reform 8.5 x 70mm polyaxial pedicle screw (39-pa-8570) fractured.The screw was ultimately extracted using a rod.The screw head broke completely off during the final stage of removal.While inserting a new screw, the tip of the polyaxial driver assembly reform pedicle screw system (39-sp-0730) broke.A rod was used to remove the screw as the driver tip was stuck in the screw head, and the procedure was successfully completed without further issue.There was a five (5) minute delay to the procedure as a result of the issues reported.
Additional Manufacturer Narrative
H3 device evaluation - visual examination of the device noted the screw fractured at the neck exhibits failure due to torsional overload since the fracture plane is normal to the longitudinal axis.Review of device history records found 15 pieces of this lot released for distribution on 7/16/2019 with no deviation or anomalies.Two year complaint history review ((b)(6) 2023-(b)(6) 2025) found this to be the only report for any of the part number in the refom polyaxial pedicle screw family in this two-year time frame.No corrective actions are recommended.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 23936080
• Report Number: 3005739886-2025-00026
• Device Sequence Number: 17549370
• Product Code: MNI
• UDI-Device Identifier: 00840019900515
• UDI-Public: (01)00840019900515(11)190716(10)25078PS
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K121172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: 39-PA-8570
• Device Catalogue Number: 39-PA-8570
• Device Lot Number: 25078PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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: Unknown