MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; 5.5MM STRAIGHT ROD, HEX-ENDED, COCR, 400MM

Model Number 724.720

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 06/21/2017

Event Type  malfunction  

Event Description

It was reported a revision was performed of a t8-iliac posterior spinal fusion due to fractured double cocr rods on both sides at the l5-s1 levels.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.Possible causes for rod fractures are pseudoarthrosis, excessive rod bending/contouring, or excessive in-vivo forces causing fatigue fracture.The exact cause of the reported issue cannot be determined.

• Brand Name: REVERE
• Type of Device: 5.5MM STRAIGHT ROD, HEX-ENDED, COCR, 400MM
• 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: 18809550
• MDR Text Key: 336796592
• Report Number: 3004142400-2019-00047
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1007BB
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 724.720
• Device Lot Number: MKS180AC, MKN304CC, MKM262AC
• Date Manufacturer Received: 05/31/2019
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White