MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X45MM POLYAXIAL SCREW,

Model Number 5119.1647

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2020

Event Type  Injury  

Event Description

It was reported that post-operative imaging showed that the left l4 and s1 pedicle screws were not placed properly.Revision surgery was performed to reposition.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device is pending return for evaluation.No determinations can be made at this time.

• Brand Name: CREO
• Type of Device: CREO THREADED 6.5X45MM POLYAXIAL 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: 18827140
• MDR Text Key: 336797961
• Report Number: 3004142400-2020-00074
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095104158
• UDI-Public: 00889095104158
• 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: 03/04/2024

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 Operator: Health Professional
• Device Model Number: 5119.1647
• Device Lot Number: BAX756CH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2020
• 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 Age: 81 YR
• Patient Race: Asian