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

Model Number	64-MT-0403
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was performed utilizing the reform modular pedicle screw system.During the procedure the modular polyaxial tulip assembly reform mis pedicle screw sys (64-mt-0403) popped off of the screw.Attempts to obtain additional details have been unsuccessful to date.
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.

• Brand Name: REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM
• Common Device Name: MODULAR MIS EXTENDED TAB TULIP
• 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: 24719836
• Report Number: 3005739886-2026-00019
• Device Sequence Number: 12272166
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: (01)00840019940610(11)260114(10)54139PS
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• 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): 02/17/2026

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: 64-MT-0403
• Device Catalogue Number: 64-MT-0403
• Device Lot Number: 54139PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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
• Patient Sex: Unknown