MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 5.5 POLYAXIAL TULIP,

Model Number 7146.0100

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in the patient.The imaging provided showthe right s2ai screw to have dissociated from the rod post-operatively.The exact cause of the reported issue could not be determined.

Event Description

It was reported that the rod disassociated from the screw head at s2 post-operatively.

• Brand Name: CREO
• Type of Device: CREO AMP 5.5 POLYAXIAL TULIP,
• 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: 18816503
• MDR Text Key: 336818115
• Report Number: 3004142400-2020-00079
• Device Sequence Number: 1
• Product Code: NKB
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7146.0100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other