MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CANOPY; CANOPY 2.6MM SCREW, SELF-DRILLING, 6MM,

Model Number 1102.6006

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in lhe patient.Imaging snows a canopy aaiacem style shelf plate was used at c3.The loosened screw is in the cephalad lateral mass screw hole.The surgeon reported that the loose screw is not life threaten ing and the patient is showing no signs of adverse effects.There are no scheduled surgeries to explant the screw at this time.An exact cause of the reported issue could not be determined.The following sections have been updated for this supplemental report: b4, e1, h2, h6, and h10.

Event Description

It was reported that the c3 screw loosened approximately three months post-operatively.

• Brand Name: CANOPY
• Type of Device: CANOPY 2.6MM SCREW, SELF-DRILLING, 6MM,
• 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: 18816802
• MDR Text Key: 336664916
• Report Number: 3004142400-2020-00082
• Device Sequence Number: 1
• Product Code: NQW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121732
• 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: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1102.6006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• 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: 73 YR
• Patient Sex: Male
• Patient Race: Asian