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

Model Number	1119.0110
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device nor any imaging was available for evaluation.It was reported that a revision was performed to replace a creo screw head that was found separating from the shank post operatively.Pieces of metal were also removed from the patient.The patient had an l5-s1 fixation and it was noted on x-ray and ct imaging that the head of the screw did not appear to be attached to the screw shank.The patient underwent a revision surgery and it was confirmed that the head was not attached to the shank of the screw.The parts were removed including two separate pieces of metal wear from under the screw head.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 was performed to replace a creo screw head that was found separating from the shank post operatively.Pieces of metal were also removed from the patient.This event occurred in germany. .
Event or Problem Description
It was reported that a revision was performed to replace a creo screw head that was found separating from the shank post operatively.Pieces of metal were also removed from the patient.This event occurred in germany.
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.It was reported that a revision was performed to replace a creo screw head that was found separating from the shank post operatively.Pieces of metal were also removed from the patient.The patient had an l5-s1 fixation and it was noted on x-ray and ct imaging that the head of the screw did not appear to be attached to the screw shank.The patient underwent a revision surgery and it was confirmed that the head was not attached to the shank of the screw.The parts were removed including two separate pieces of metal wear from under the screw head.No determinations could be made as to the cause of the reported issue.The following sections are been updated for this supplemental: b4; b6; e1; g6; h2; h3; h10.

• Brand Name: CREO
• Common Device Name: CREO AMP THREADED 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: 18810898
• Report Number: 3004142400-2023-00202
• Device Sequence Number: 8283121
• Product Code: MNH
• UDI-Device Identifier: 00889095059656
• UDI-Public: 00889095059656
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 06/20/2025

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: 1119.0110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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