MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP

Model Number	1119.0010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a creo threaded locking cap was found loose post operatively.
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.It was reported that a revision was required for a creo threaded locking cap migrated post operatively.The original implant date was (b)(6) 2024 and it was discovered migrated on(b)(6) 2024.The construct was a fusion from l2-l5.The left l2 locking cap was seen completely disassociated from the screw head in returned lateral and ap x-ray images.The locking cap was not returned because there has not been a revision performed; the patient is asymptomatic and being closely monitored.The post-operative conditions are unknown, so it can't be established if there was any excessive force that may have caused the locking cap to migrate.It was confirmed that the surgeon stated he final tightened the locking cap per the technique guide.Because the exact surgical conditions cannot be replicated, no determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: CREO THREADED LOCKING CAP
• 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: 19309769
• Report Number: 3004142400-2024-00084
• Device Sequence Number: 7009906
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• 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 Implanted 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): 05/13/2024

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: 1119.0010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/14/2024
• 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: 71 YR
• Patient Sex: Male