MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM MIDLINE CORTICAL SCREW SYSTEM; MODULAR POLYAXIAL TULIP

Model Number	59-MT-0301
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event - not provided h3 device evaluation - evaluation of device was not required as the investigation concluded that the suspect device was inadvertently placed in the incorrect tray by the distributor's office and went undetected until it was implanted and unable to accept the mating rod component.Review of device history records found fifty (50) pieces of lot 53934ps were released for distribution on (b)(6) 2026 with no deviation or anomalies.Two-year complaint history review found this to be the only report of this nature for the reported part number.No corrective actions are being recommended.
Event or Problem Description
It was reported that a procedure was perfomed on an unknown date utilizing the reform pedicle screw system.While having issues attempting to insert a lordotic ti rod, 5.50 x 35mm (39-lt-5035) it was noted by the surgeon that one of the tulip heads appeared to be a ø4.75 standard screw tulip (59-mt-0301).The tulip and screw were removed and replaced with the correct size tulip, and a new rod was successfully placed to complete the procedure.There was no patient injury but there was a twenty minute delay as a result.

• Brand Name: REFORM MIDLINE CORTICAL SCREW SYSTEM
• Common Device Name: MODULAR POLYAXIAL 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: 24653939
• Report Number: 3005739886-2026-00018
• Device Sequence Number: 6087595
• Product Code: NKB
• UDI-Device Identifier: 00815362027196
• UDI-Public: (01)00815362027196(11)260129(10)53934PS
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173130
• 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): 02/23/2026

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: 59-MT-0301
• Device Catalogue Number: 59-MT-0301
• Device Lot Number: 53934PS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown