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

Model Number	7146.0110
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation in the locked position.There were minor signs of wear upon one of the clamps and there were marks on the saddle where the rod made contact.There is also wear on the top of the rod where the locking caps were engaged and signs of wear upon both of the bottoms of the locking caps where they contacted the rod.There is a significant amount of wear along the threads of one of the locking caps and both locking caps have thread shavings present.Finally, there is a small amount of biomaterial stuck between the saddle and the tulip.It is possible that biomaterial was between the clamp and the screw head or that it lodged between the saddle and the screw head during assembly in-situ which caused the saddle not to lock properly.However, no determinations could be made as to the cause of the reported issue.The following sections are been updated: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported that a revision surgery was needed to replace a creo amp threaded polyaxial tulip screw head that had separated from the shank post operatively. .

• Brand Name: CREO
• Common Device Name: CREO AMP THREADED POLYAXIAL TULIP, COCR
• 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: 18837869
• Report Number: 3004142400-2023-00150
• Device Sequence Number: 7132939
• Product Code: NKB
• UDI-Device Identifier: 00889095200874
• UDI-Public: 00889095200874
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7146.0110
• Device Lot Number: BAA48BUB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown