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)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number - unknown.D4: primary unique device identification (udi) number - full udi number not available without lot identification.H4: device manufacture date - unknown without lot identification.H3: device evaluation - no product was returned for evaluation.Without the opportunity to examine the complaint product, no conclusion can be drawn regarding the disassembly reported.It was noted that the tulip was successfully reattached to the screw to complete the procedure.Review of device history records and lot specific complaint history review were not possible.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2026, in australia, utilizing the reform ct pedicle screw system.The modular polyaxial tulip assembly reform mis pedicle screw system (64-mt-0403) was assembled on a 5-bp-xxxx series screw by the nurse and checked that it was secure.The screw was then assembled onto a navigated/assembled screwdriver.The surgeon placed the screw in the pedicle and upon removing the screwdriver, the tulip fell off and into the surgical site.It was recovered and reassembled, with a bit of difficulty, to complete the procedure.

• 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: 25585273
• Report Number: 3005739886-2026-00027
• Device Sequence Number: 17580668
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: (01)00840019940610
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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-MT-0403
• Device Catalogue Number: 64-MT-0403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown