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

Model Number	1119.0010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reoorted that a creo lockinq cap backed out post-operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.It was reported that a creo locking cap backed out post-operatively.Osteomyelitis can affect patient anatomy and result in atypical loading of implants.Due to this and other variables, it is not possible to determine the forces on the implant and how they may or not have affected it's loosening.The exact cause remains unknown due to the inability to evaluate the implant or the implants position, or the root cause of the observed pain.The following sections have been updated: b4, e1, e3, h2, h6, h10.

• 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: 18839367
• Report Number: 3004142400-2020-00024
• Device Sequence Number: 7132487
• 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
• 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): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/06/2020
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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