MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI CT MODULAR MIS PEDICLE SCREW; 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	06/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 lot number - unknown.H4 device manufacture date - unknown without lot identification.H3 device evaluation - the complaint device was ultimately implanted and cannot be returned for evaluation.Without the opportunity to examine the complaint product no conclusions can be drawn regarding the root cause of the reported malfunction.Review of device history records and lot specific complaint history review were not possible without lot identification.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 in australia on (b)(6) 2024, utilizing the reform ti mis ct screw system.The modular polyaxial tulip assembly reform mis pedicle screw sys (64-mt-0403) was assembled to a 59-bc-xxxx midline cortical bone screw, cannulated and being inserted with a standard navigated reform ct screwdriver the tulip disassembled from the screw.It was then snapped back onto the screw and successfully implanted.There was no patient injury reported but there was a five (5) minute delay to the procedure.

• Brand Name: REFORM TI CT MODULAR MIS PEDICLE SCREW
• 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: 19690119
• Report Number: 3005739886-2024-00036
• Device Sequence Number: 7122150
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: 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
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 64-MT-0403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/08/2024
• 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
• Patient Sex: Unknown