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

Catalog Number 64-MT-0403

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  Injury  

Event Description

It was reported that an l5-s1 ct mis procedure was performed on (b)(6) 2023, utilizing the reform ct mis pedicle screw system.During the procedure four (4) ø6.5mm x 40mm reform ti modular cannulated screws (39-sk-6540) were removed from the caddy and the modular polyaxial tulip assembly reform mis pedicle screw system (64-mt-0403) was snapped on by hand.They were then given the slightest tug.The surgeon placed the screws on the left side, allowing the pa to place the right side screws.On the first screw at l5 on the left side the tulip disassembled.The screw was removed with the height adjuster and new screw and tulip readily available in the set were placed with no further issue.There was no patient injury with a slight delay of 3-5 minutes.

Manufacturer Narrative

H3 device evaluation - the parts were reviewed under magnification and the only damage noted was some deformation to the hexalobe, which is assumed to have occurred during extraction of the screw.The tulip and screw easily and audibly clicked together without issue.The assembly was then torqued down with a rod and cap-screw - once again without any observed issues.It is unclear as to why the disassembly occurred.Mechanical testing of properly assembled reform ti modular screws upon which this design is based demonstrates that reform ti modular assemblies are as strong as preassembled reform ti and slok polyaxial screws.Review of device history records found (b)(4) of lot 44286ps released for distribution on 6/2/2023 with no deviation or anomalies.Two-year complaint history review (7.31.2021-7.1.2023) found this to be the only report of this nature for this lot.Further review for all lots did not reveal a trend for reports of this nature.Although there was no product non-conformance identified, corrective actions were implemented by marketing to update the surgical technique guide to add additional instruction for tulip assembly.

• Brand Name: REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM
• Type of Device: 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: 17624860
• MDR Text Key: 321968303
• Report Number: 3005739886-2023-00040
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: 00840019940610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 64-MT-0403
• Device Lot Number: 44286PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention