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

Model Number 185.000

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device not any images were available for evaluation as it remains in the patient.It was reported that a revolve locking cap (185.000) went through the psoas and was lost near the peritoneum in a surgery from t7-l3.Without more information it is impossible to determine how the locking cap went through the psoas and if it relates to an instrument or implant malfunction.No determinations could be made as to the cause of the reported issue.The following sections are been updated: b4, e1, h2, h6, h10.

Event Description

It was reported that during surgery a revolve locking cap went through the psoas and was lost near the peritoneum and left in the patient post operatively.This event occurred in austria.

• Brand Name: REVOLVE
• Type of Device: REVOLVE 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: 18827147
• MDR Text Key: 336789441
• Report Number: 3004142400-2024-00004
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00849044070569
• UDI-Public: 00849044070569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2024

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
• Device Operator: Health Professional
• Device Model Number: 185.000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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