MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI MODULAR; MODULAR PEDICLE SCREW

Catalog Number 39-SK-6540

Device Problem Use of Device Problem (1670)

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

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Lot number - unknown, occupation - other; distributor, device manufacture date - unknown.Device evaluation - without the opportunity to examine the complaint product, no conclusions can be drawn regarding the case of the reported malfunction.Review of device history records could not be performed without lot identity.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2022-00040).

Event Description

It was reported that a one-level procedure was performed on an unknown date, utilizing the reform mis ti ct pedicle screw system.It was noted during final radiographs taken during the procedure show that one of the modular polyaxial tulip assembly reform mis pedicle screw ((b)(4)) was not assembled to the screw.The screw was then removed and replaced with a new screw/tulip assembly.There was no patient injury but a 20-30 minute delay resulted.The disassembled product was discarded in the operating room.

• Brand Name: REFORM TI MODULAR
• Type of Device: MODULAR PEDICLE SCREW
• 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 dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 16024223
• MDR Text Key: 305912754
• Report Number: 3005739886-2022-00041
• Device Sequence Number: 1
• Product Code: KWP
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39-SK-6540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 49 YR