MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM; SCREWDRIVER

Model Number	64-SP-1700
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 lot number: not available.D4 unique device identifier (udi) number: full number not available without lot identification h4 device manufacture date: unknown without lot identification h3 device evaluation: evaluation is not possible as the device was discarded by the hospital.Review of manufacturing records and lot specific complaint history review are not possible without lot identification.Two-year complaint history review (6.5.2024-6.5.2026) found this to be the only report for this part number.Without the opportunity to examine the complaint product, no conclusions can be drawing regarding the cause of the device failure.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2026.After placement of the screw the surgeon went back to adjust.The adjustment could not be made with the adjustment driver (64-sp-0601) so he asked for the globus robot driver (75-rt-1750) so much force was applied when trying to turn the screw the driver snapped near handle.We then tried using the (64-sp-1700) and the same result occurred.We then placed a rod in the tulip and attempted to use a shukla to helicopter it out.This resulted in the neck of the screw snapping.Now with the shank of the screw left in the patient we used a shukla broken stripped screw extractor and were able to remove the remainder of the screw.There was no patient injury, but there was a twenty (20) minute delay to the procedure as a result of the malfunctions.

• Brand Name: REFORM TI CT MODULAR MIS 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: 25667761
• Report Number: 3005739886-2026-00031
• Device Sequence Number: 5638957
• Product Code: HXX
• UDI-Device Identifier: 00840019942454
• UDI-Public: 00840019942454
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 64-SP-1700
• Device Catalogue Number: 64-SP-1700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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