MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 1194.2032

Device Problems Device Slipped (1584); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

Patient having anterior cervical diskectomy and fusion at c5-c6.C6-c7.Upon placement of plate and screws, surgeon noticed the third screw went through the plate and into bone directly without having any to minimal contact with plate.Surgeon removed the plate and three screws and replaced them with a different and type of plate and screws.The defected plate and screws disinfected and sequestered.

• Brand Name: RESONATE
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave; valley forge business center; audubon PA 19403
• MDR Report Key: 12106494
• MDR Text Key: 259610553
• Report Number: 12106494
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2021,06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1194.2032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2021
• Date Report to Manufacturer: 07/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA