MAUDE Adverse Event Report: Precision Spine, Inc Reform Ti CT Modular MIS Pedicle Screw System; Lock Screw

Model Number	64-LS-0100
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Reform Ti CT Modular MIS Pedicle Screw System
• Common Device Name: Lock 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 ; +1(601)420-4244
• MDR Report Key: 50091951
• Report Number: 3005739886-2026-00032
• Device Sequence Number: 9816525
• Product Code: NKB
• UDI-Device Identifier: 00840019942768
• UDI-Public: (01)00840019942768(11)250422(10)51754PS
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/21/2026

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-LS-0100
• Device Catalogue Number: 64-LS-0100
• Device Lot Number: 51754PS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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