MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SP-FIX; SP-FIX PLATE

Device Problem Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device could not be provided as it was discarded at the hospital.The information provided does not indicate an implant failure as the cause of the revision surgery.The report states that the broken hex tip was safely removed from the patient and disposed of.No determinations can be made as to the cause of the reported issue.The following sections are been updated: b4, e1, h2, h6, h10.

Event Description

It was reported that a revision surgery was needed to remove an sp-fix plate for a fusion that failed post operatively.

• Brand Name: SP-FIX
• Type of Device: SP-FIX PLATE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18837343
• MDR Text Key: 336897824
• Report Number: 3004142400-2023-00183
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D154976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2023
• 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): Other