MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 8.5X80MM POLYAXIAL SCREW, COCR HEAD, TI SHANK

Model Number 5146.1882

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2020

Event Type  malfunction  

Event Description

It was reported that a screw head disassociated from the shank post-operatively.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.It was reported that a screw head disassociated from the shank post-operatively.The implant and x-rays were not provided for visual inspection, therefore no visual assessment of the implant or it's placement could be performed.The exact cause remains unknown due to the inability to evaluate the implant or the implants position, intraoperative conditions, or the root cause of the observed pain.

• Brand Name: CREO
• Type of Device: CREO THREADED 8.5X80MM POLYAXIAL SCREW, COCR HEAD, TI SHANK
• 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: 18823382
• MDR Text Key: 336814244
• Report Number: 3004142400-2020-00020
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095130522
• UDI-Public: 00889095130522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143633
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5146.1882
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1