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

Device Problems Misassembled (1398); Output Problem (3005)

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

Event Date 07/06/2022

Event Type  malfunction  

Event 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 the tulip back onto the screw and successfully complete the procedure with no delay to the procedure or injury to the patient.

Manufacturer Narrative

Patient information: unknown.Lot number: unknown.Occupation: other; distributor.Device manufacture date: unknown.Device evaluation: although it cannot be confirmed, based on the information provided it appears that the cause of the tulip disassembling from the screw during rod insertion may be attributed to incomplete assembly prior to implantation of the screw.This would be supported with the fact that the surgeon was able to snap the tulip back onto the screw and complete the procedure with no further issues reported.Without lot identification, manufacturing history review could not be performed.Review of device history records was not possible without lot identification.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.

• 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 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: 15225369
• MDR Text Key: 303433692
• Report Number: 3005739886-2022-00025
• 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: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 64-MT-0403
• Device Catalogue Number: 64-MT-0403
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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