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

Catalog Number 39-SB-6555

Device Problem Fracture (1260)

Patient Problem Implant Pain (4561)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

H3- evaluation in process, not yet complete.A follow-up report will be filed upon completion of investigation.This report is number 1 of 3 mdrs filed for the same event (reference 3005739886-2023-00018).

Event Description

It was reported that an l4/l5/s1 procedure was performed on (b)(6) 2023, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, the patient presented with pain and radiographical analysis showed compression of the construct and three (3) broken ø6.5mm x 55mm reform ti modular cannulated screws (39-sk-6555).A revision procedure was performed on (b)(6) 2024, during which all hardware was removed and replaced, with the exception of one side of l5 where tip portion of the broken screw remains.

• Brand Name: REFORM TI PEDICLE SCREW SYSTEM
• Type of Device: MODULAR BONE 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 drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 18935454
• MDR Text Key: 338043144
• Report Number: 3005739886-2024-00016
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 00840019931977
• UDI-Public: 00840019931977
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39-SB-6555
• Device Lot Number: 26902PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2019
• 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