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

Model Number	39-SP-0730
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 device evaluation - the driver's tip is sheared off.The fracture plane is normal to the driver's longitudinal axis.This type of fracture is indicative of a torsional overload condition.Review of device history records (ir22-0381) found on piece of was received from supplier, instru-med, and released for distribution on 3/29/2022 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective action is recommended.
Event or Problem Description
It was reported that the patient underwent a procedure on (b)(6) 2024, utilizing the reform pedicle screw system.A revision procedure was performed on (b)(6) 2025 to extend the existing construct.During the procedure it was noted that one of the ø6.5mm x 50mm reform ti modular non-cannulated - non-fluted screw (39-sg-6550) was fractured.The broken screw was removed and replaced with new hardware.It was also noted that while implanting a screw the tip of the t20 polyaxial driver reform pedicle screw system (39-sp-0730) broke.The tip was removed and the procedure completed with no further issue and no harm to the patient.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• 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: 22834571
• Report Number: 3005739886-2025-00015
• Device Sequence Number: 4564885
• Product Code: HXX
• UDI-Device Identifier: 00815362022016
• UDI-Public: (01)00815362022016(11)29032022(10)01701IMR
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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: 39-SP-0730
• Device Catalogue Number: 39-SP-0730
• Device Lot Number: 01701IMR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown