MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 9.5X80MM POLYAXIAL SCREW,

Model Number 5119.1982

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the devices or any imaging were available for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a creo screw head disassociated from the screw shank post-operatively, requiring revision surgery.

• Brand Name: CREO
• Type of Device: CREO THREADED 9.5X80MM 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: 18830244
• MDR Text Key: 336815688
• Report Number: 3004142400-2019-00034
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095106077
• UDI-Public: 00889095106077
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.1982
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2019
• 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: 66 YR
• Patient Sex: Male