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

Catalog 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	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024, utilizing the reform mis pedicle screw system.The modular polyaxial tulip assembly reform mis pedicle screw sys (64-mt-0403) was being loaded onto the screw shank outside of the caddy using axial force to connect the two parts.A click was heard, and the scrub tech then tested the connection by pulling the screw shank and gold tulip in opposite directions per the instructions in the surgical technique guide.As the screw was advanced into the pedicle, the tulip popped off of the screw shank and remained threaded onto the driver as the tulip hit the facet.The screw shank was backed out of the bone a couple of turns and a different gold tulip was pushed onto the shank before it was put back into position.We were able to finish the case without any further incident.There was no patient injury reported but a five (5) minute delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - the tulip was visually examined and then functionally assessed.The snap ring and the tulip's opening that accepts the screw do not exhibit gross deformation.A mating bone screw was then assembled to the tulip and pulled on to assess the connection.A reform ti ct screwdriver, 64-sp-1700, was threaded onto the screw assembly and then driven into a simulated lumbar spine model that included simulated soft tissue (symgery's lumbar model).The screw was buried against the simulated bone and the driver was levered on in an attempt to dislodge the tulip from the screw.The screw assembly remained rigidly fixed together.The pins of the tulip were drilled out to access the internal components of the assembly.Evaluation was able to verify that the correct components were used in the assembly.The 64-tt-0403 tulip and 39-sr-0404 snap ring was sectioned for internal inspection.All dimensions that were able to be inspected measured within tolerance.The visual, functional and dimensional evaluation did not yield any information that would support a disassembly issue with properly assembled screw - tulip assemblies.Review of device history records found 114 pieces of lot 48389ps released for distribution on 5/29/2024 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.The cause for the reported disassembly remains unknown.No corrective actions are recommended.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024, utilizing the reform mis pedicle screw system.The modular polyaxial tulip assembly reform mis pedicle screw sys (64-mt-0403) was being loaded onto the screw shank outside of the caddy using axial force to connect the two parts.A click was heard, and the scrub tech then tested the connection by pulling the screw shank and gold tulip in opposite directions per the instructions in the surgical technique guide.As the screw was advanced into the pedicle, the tulip popped off of the screw shank and remained threaded onto the driver as the tulip hit the facet.The screw shank was backed out of the bone a couple of turns and a different gold tulip was pushed onto the shank before it was put back into position.We were able to finish the case without any further incident.There was no patient injury reported but a five (5) minute delay to the procedure.
Additional Manufacturer Narrative
Hold for cs 11/04/2024 the tulip was visually examined and then functionally assessed.The snap ring and the tulip's opening that accepts the screw do not exhibit gross deformation.A mating bone screw was then assembled to the tulip and pulled on to assess the connection.A reform ti ct screwdriver, 64-sp-1700, was threaded onto the screw assembly and then driven into a simulated lumbar spine model that included simulated soft tissue.The screw was buried against the simulated bone and the driver was levered on in an attempt to dislodge the tulip from the screw.The screw assembly remained rigidly fixed together.The cause for the issue remains unknown.The pins of the tulip were drilled out to access the internal components of the assembly.Verified that the correct components were used in the assembly.The 64-tt-0403 tulip and 39-sr-0404 snap ring was sectioned for internal inspection.All dimensions that were able to be inspected measured within tolerance.The visual, functional and quality evaluation did not yield any information that would support a disassembly issue with properly assembled screw - tulip assemblies.Tulip disassociation is a known hazard identified in current risk documentation.Review of device history records found (b)(4) pieces of lot 48389ps released for distribution on 5/29/2024 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are being recommended.

• Brand Name: REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM
• Common Device Name: MODULAR 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: 20355332
• Report Number: 3005739886-2024-00046
• Device Sequence Number: 8127103
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: (01)00840019940610(11)240521(10)48389PS
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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 Catalogue Number: 64-MT-0403
• Device Lot Number: 48389PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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