MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; ROD

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.Open-open clamps and single connectors must always be used in pairs.The imaging provided shows these single connectors were not used in pairs at their connection point to the primary construct, which may have reduced construct strength.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported that the connection between the connectors and rod had slid post-operatively.

• Type of Device: ROD
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 10582877
• MDR Text Key: 209578292
• Report Number: 3004142400-2020-00121
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/18/2020

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
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other