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
Additional Manufacturer Narrative
D4: lot number: unknown.D4: primary unique device identifier (udi) number - unknown without lot identification.H3: device evaluation in process.A follow-up report will be submitted upon completion.
Event or Problem Description
It was reported that a one level reform ct case at l4-5 was performed on an unknown date.The right l4 ct tulip disengaged while set screw was being placed.Tulip was reengaged using the tab breaker, rod and set screw were placed in standard fashion.I monitored the scrub tech assemble the right-side screws to confirm they were snapped together properly.After insertion, left side l4 tulip disengaged prior to rod insertion.The tulip was replaced, and the prior one was set aside for inspection.There was no patient injury but a delay of 15 minutes to the procedure.
Event or Problem Description
It was reported that a one level reform ct case at l4-5 was performed on an unknown date.The right l4 ct tulip disengaged while set screw was being placed.Tulip was reengaged using the tab breaker, rod and set screw were placed in standard fashion.I monitored the scrub tech assemble the right-side screws to confirm they were snapped together properly.After insertion, left side l4 tulip disengaged prior to rod insertion.The tulip was replaced, and the prior one was set aside for inspection.There was no patient injury but a delay of 15 minutes to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - tulip was inspected with a 7x loop prior to assembling with a screw observing no damage or deformation to components.Disassembly could not be replicated.The tulip-screw assembly was subsequently disassembled by drilling out the pins.The subcomponents were inspected and found to be within specification.Further assessments were performed using these components and gage pins to secure the assembly.Simulated implantation into 20 pcf foam was performed with these components multiple times.Again, the ability to disassemble the screw from the tulip was not demonstrated.The tulip was further examined with the aid of a 5x loop.Some deformation was observed around a small segment of the bottom opening where the screw extends thru the tulip.This may be due to the force applied during prior assessments.Disassembly is believed to be due to improper assembly as all assessments and tests to date have not been able to replicate this condition with properly assembled components, including components returned as complaint product.Although the need for corrective action has not been established, it is being recommended that information associated with proper assembly techniques be reviewed and updated if deemed appropriate, additional techniques / tips be explored, and/or a tool to aid in attaining proper assembly be developed and provided to sites exhibiting potential assembly issues.Review of device history records (50225_64-mt-0403) for the returned tulip found eighty-five (85) pieces of lot 50225ps released for distribution on 11/7/2024 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.

• 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: 20942474
• Report Number: 3005739886-2024-00064
• Device Sequence Number: 19961844
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: (01)00840019940610(11)241105(10)50225PS
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 50225PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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