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

Catalog Number 39-SK-65XX

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

It was reported that a procedure was performed in australia by dr.(b)(6), on an unknown date, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, the patient presented with pain and it was discovered that one of the ø6.5mm x xxmm reform ti modular cannulated screws (39-sk-65xx) broke.A revision date has not yet been scheduled.Subsequent contact with the surgeon by the distributor noted that the patient's pain has subsided, and the surgeon and patient decided that no revision would be performed at this time.

Manufacturer Narrative

H3 device evaluation - product is not available for evaluation.No conclusion can be drawn as to the cause of the reported screw breakage.Without lot identity device history review and lot specific complaint history review are not possible.Two-year complaint history review did not reveal a trend for reports of this nature for this product family.

• Brand Name: REFORM TI MODULAR
• Type of Device: MODULAR BONE SCREW, CANNULATED
• 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: 18924703
• MDR Text Key: 337914752
• Report Number: 3005739886-2024-00015
• Device Sequence Number: 1
• Product Code: KWP
• 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: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 39-SK-65XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• 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