MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. MONUMENT; MONUMENT SPACER, MEDIUM, 15°, 15MM

Model Number	3108.0515
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it remains in the patient.Inspection of the intraoperative lateral images snow me implant to be fully reduced with all four screws inserted into the implant.Post-operative lateral images show what appears to be one of the inferior screws sitting proud of the plate.No determinations can be made as to the cause of the reported issue.The following sections have been updated: b4, e1, e3, h2, h6, h10.
Event or Problem Description
It was identified during a follow-up visit on (b)(6) 2018, that one screw appeared to be backing out of the monument spacer.The patient is not experiencing any adverse reactions and a revision is not planned at this time.

• Brand Name: MONUMENT
• Common Device Name: MONUMENT SPACER, MEDIUM, 15°, 15MM
• 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: 18825838
• Report Number: 3004142400-2018-00037
• Device Sequence Number: 18126388
• Product Code: OVD
• UDI-Device Identifier: 00889095085266
• UDI-Public: 00889095085266
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2024

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: 3108.0515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Sex: Male
• Patient Race: White