MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. MONUMENT; MONUMENT SPACER, LARGE, 8°, 13MM

Model Number 3108.0713

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Comparison of the imaging taken two weeks and twelve weeks post-operatively shows the monument spacer has lost the reduction acheived during surgery.The device was not available for evaluation as it remains in the patient, making a full evaluation not possible.The exact cause of the reported issue cannot be determined.

Event Description

It was reported that a monument spacer collapsed post-operatively.

• Brand Name: MONUMENT
• Type of Device: MONUMENT SPACER, LARGE, 8°, 13MM
• 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: 18829709
• MDR Text Key: 336813918
• Report Number: 3004142400-2019-00019
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00889095085310
• UDI-Public: 00889095085310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3108.0713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male