MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP THREADED POLYAXIAL TULIP

Model Number 1119.0110

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The fall may have placed excessive force on the screw/unilateral construct, causing the reported issue.The following sections have been updated: b4, e1, e3, h2, h6, h10.

Event Description

The patient reported to the surgeon that they had fallen (date not provided}.X-rays show that 3 screws pulled out of the bone and 1 screw head pulled off of the screw shank of a fourth screw.Revision surgery was performed, the hardware was replaced and the construct was extended.

• Brand Name: CREO
• Type of Device: CREO AMP THREADED POLYAXIAL TULIP
• 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: 18825601
• MDR Text Key: 336761267
• Report Number: 3004142400-2018-00029
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095059656
• UDI-Public: 00889095059656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124058
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1119.0110
• Device Lot Number: BAU176XF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male