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 Mechanical Problem (1384)

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

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

Review of device history records and lot specific complaint history is not possible without lot identification.Two-year complaint history review (4.24.2021-4.24.2023) did not identify a trend for reports of this nature for the reported part number.Without the opportunity to examine the complaint product, no conclusions can be drawn regarding the root cause of the reported malfunction.No corrective actions are required as the root cause cannot be determined.

Event Description

It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform ti mis ct pedicle screw system.During the procedure the modular polyaxial tulip assembly (64-mt-0403) was assembled on the screw by the surgical tech on the back table.After popping the tulip on the head, the tech pulled on the screw to make sure it was attached to the tulip.After the construct was assembled with the rods in place, it was noted on x-rays that the rod was not in the position with the screw.The surgeon removed the rod and realized that the tulip was no longer assembled on the screw.Then the screw was backed up to attach a new tulip.The rod and set screws were then placed and the procedure completed with no further issue.There was no patient injury reported but a 5-10 minute delay to the procedure due to the tulip malfunction.The tulip was discarded and is not available for evaluation.

• 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: 16864636
• MDR Text Key: 314505849
• Report Number: 3005739886-2023-00013
• Device Sequence Number: 1
• Product Code: NKB
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64-MT-0403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2023
• 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
• Patient Outcome(s): Required Intervention