MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI MODULAR; SCREWDRIVER

Model Number	39-SP-0750
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that a revision procedure for competitor product was performed on (b)(6) 2025, utilizing the reform ti pedicle screw system.While inserting a 9.5 x 70mm reform ti screw into the iliac, the tip of the t25, polyaxial driver assembly cannulated, reform ti (39-sp-0750) broke.The screw was removed an replaced utilizing the second driver readily available in the set.No patient injury or delay to the procedure resulted from the reported malfunction.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver is sheared off.The fracture plane is normal to the drive axis.This type of failure is indicative of breakage due to torsional overload.Review of device history records found eight (8) pieces of lot 00916up released for distribution on (b)(6) 2022 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.No corrective actions are recommended at this time.
Event or Problem Description
It was reported that a revision procedure for competitor product was performed on (b)(6) 2025, utilizing the reform ti pedicle screw system.While inserting a 9.5 x 70mm reform ti screw into the iliac, the tip of the t25, polyaxial driver assembly cannulated, reform ti (39-sp-0750) broke.The screw was removed an replaced utilizing the second driver readily available in the set.No patient injury or delay to the procedure resulted from the reported malfunction.

• Brand Name: REFORM TI MODULAR
• Common Device Name: SCREWDRIVER
• 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: 23569536
• Report Number: 3005739886-2025-00018
• Device Sequence Number: 9885552
• Product Code: HXX
• UDI-Device Identifier: 00840019932455
• UDI-Public: (01)00840019932455(11)220202(10)00916UP
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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-SP-0750
• Device Catalogue Number: 39-SP-0750
• Device Lot Number: 00916UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown