MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XTEND; XTEND ANTERIOR CERVICAL PLATE

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging were available for evaluation.No determinations can be made as to the cause of the reported issue.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.

Event Description

It was reported that a fortify spacer lost height post-operatively.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available to be returned for evaluation.No determinations can be made as to the cause of the reported issue.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.

Event Description

It was reported that two screws backed out of the xtend plate post-operatively.

• Brand Name: XTEND
• Type of Device: XTEND ANTERIOR CERVICAL PLATE
• 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: 18808424
• MDR Text Key: 336796104
• Report Number: 3004142400-2019-00057
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092146
• 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,Followup
• Report Date: 02/29/2024

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: Health Professional
• Date Manufacturer Received: 07/24/2019
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: Black Or African American