MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X40MM POLYAXIAL SCREW

Model Number	5119.1642
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.Our investigation of the provided x-ray images indicated that the screw head of the preassembled screw had come off of the screw shank of the left l4 screw.The original surgery completed in (b)(6) 2021 was a fusion from l3 to s1.The screw head was seen disassembled from the screw shank prior to the revision surgery, after a reported workplace incident.The revision surgery planned to remove locking caps and extend the construct to l3, however this plan was abandoned after the surgeon was unable to remove the locking caps from the screw heads and resorted to cutting the rod and helicoptering the screws out.The screws were replaced with another company and the case was completed.It is possible that there was excessive in-situ forces placed on the top of the construct during the reported workplace incident that may have attributed to head pull-off of the screw.However, because these forces and surgical conditions cannot be replicated the exact cause of pull-off cannot be determined.The observed overall risk level is low, which matches the observed anticipated risk level; therefore, the overall risk of the system has been maintained.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was needed to replace creo threaded screws that were found broken post operatively.

• Brand Name: CREO
• Common Device Name: CREO THREADED 6.5X40MM 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: 20042479
• Report Number: 3004142400-2024-00187
• Device Sequence Number: 7970826
• Product Code: MNH
• UDI-Device Identifier: 00889095104127
• UDI-Public: 00889095104127
• 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: 2024
• 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): 08/22/2024

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: 5119.1642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Race: White