MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO PEDICLE SCREW

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it was discarded by the hospital.Inspection of the imaging provided confirmed the failed fusions and shows the screw pullout from the left pedicle at t12, left pedicle at l1, and left pedicle at s1.It's possible that poor bone quality due to recurring epidural abscesses and infection contributed to the screws pulling out of the pedicles.Additionally, excessive force placed on the implant during unknown patient loading, incorrect implant selection, or incorrect screw placement could have contributed.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported that the creo pedicle screw had loosened within the patient's bone post-operatively.

• Brand Name: CREO
• Type of Device: CREO PEDICLE SCREW
• 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: 18826042
• MDR Text Key: 336776925
• Report Number: 3004142400-2020-00057
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 03/04/2024
• 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
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White