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
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation - distributor.Device evaluation - information provided indicates that the product is available for evaluation, but has yet to be received.No conclusions can be drawn at this time as to the cause of the reported event.Review of device history records found (b)(4) pieces of this lot released for distribution on june 2, 2022, with no deviation or anomalies.Two-year complaint history review (7.20.2020-7.20.2022) found this to be the only report of this nature for this lot.Further review did not reveal a trend for report of this nature for this part number.No corrective actions are recommended at this time.Should the product be received, a follow-up medwatch report will be filed upon completion of investigation.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the reform ti mis ct pedicle screw system.The modular polyaxial tulip assembly reform mis pedicle screw sys (64-mt-0403) and reform ti modular cannulated screws were assembled by the tech on the back table and handed off to the surgeon.The screw/tulip assemblies were then implanted into the pedicle.Upon attempting to insert the rod through the tulips, one of the modular polyaxial tulip assemblies disassembled from the screw.The surgeon was able to snap a new tulip onto the screw and successfully complete the procedure with no delay to the procedure or injury to the patient.
Additional Manufacturer Narrative
Device evaluation - the tulip assembly was examined by eye and with a 5x loop, and then functionally assessed with a bone screw.The visual examination did not identify any anomalies.The functional assessment demonstrated that the device functioned per the design intent.The tulip snapped onto the bone screw and could not be removed.Prior assessment of this type of occurrence indicated that the tulip can be partially assembled / not seated if the individual who assembles the tulip to the bone screw does not bottom the bone screw in the tulip.A strong tug on the tulip may be needed to confirm proper assembly has occurred.No corrective actions are being recommended at this time.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the reform ti mis ct pedicle screw system.The modular polyaxial tulip assembly reform mis pedicle screw sys (64-mt-0403) and reform ti modular cannulated screws were assembled by the tech on the back table and handed off to the surgeon.The screw/tulip assemblies were then implanted into the pedicle.Upon attempting to insert the rod through the tulips, one of the modular polyaxial tulip assemblies disassembled from the screw.The surgeon was able to snap a new tulip onto the screw and successfully complete the procedure with no delay to the procedure or injury to the patient.

• 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 dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 15229282
• Report Number: 3005739886-2022-00026
• Device Sequence Number: 11954039
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: 00840019940610
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 41353PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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