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

Model Number 1119.0010

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a creo locking cap backed out of the screw head post-operatively.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it remains in the patient.Post-operative imaging shows a construct extending from t11-l4 for a burst fracture at l3.A locking cap is dislodged from the left l4 screw head.It's possible that excessive force placed on the implant during unknown patient loading or insufficient tightening of the implant may have contributed to the observed issue.However, the exact cause of the reported issue cannot be determined.

• Brand Name: CREO
• Type of Device: CREO THREADED LOCKING CAP
• 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: 18823402
• MDR Text Key: 336745549
• Report Number: 3004142400-2020-00040
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• 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: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0010
• Date Manufacturer Received: 04/09/2020
• 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
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Hispanic