MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP, BN,

Model Number 1119.0011

Device Problem Expulsion (2933)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The devices were not available for return.Imaging provided shows one locking cap visually out of the screw head at the top of the construct.Possible causes that may have contributed to the loosening include intra-operative tightening conditions, excessive post-operative loading, or unknown implant related causes.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done to replace 4 locking caps which had come loose post-operatively.

• Brand Name: CREO
• Type of Device: CREO THREADED LOCKING CAP, BN,
• 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: 18817739
• MDR Text Key: 336873663
• Report Number: 3004142400-2021-00045
• Device Sequence Number: 1
• Product Code: NKB
• 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: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No
• 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