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

Catalog Number	39-SK-6540
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005739886-2022-00041
• Device Sequence Number: 5897081
• Product Code: KWP
• UDI-Device Identifier: 00840019933612
• UDI-Public: 00840019933612
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 39-SK-6540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Unknown