MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XTEND; XTEND ANTERIOR CERVICAL PLATE, 2-LEVEL, 34MM

Model Number 164.234

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it was retained by the patient.The surgeon indicated that the set screw was in the locked position during the revision surgery and imaging provided show a set screw in the locked position at the level where the screw backed out.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that the xtend screw backed out of the plate post-operatively requiring revision surgery.The surgeon indicated that the integrated plate set screw was in the final locked position at the time of the revision.

• Brand Name: XTEND
• Type of Device: XTEND ANTERIOR CERVICAL PLATE, 2-LEVEL, 34MM
• 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: 18832441
• MDR Text Key: 336828940
• Report Number: 3004142400-2019-00028
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00849044087963
• UDI-Public: 00849044087963
• 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
• Report Date: 03/04/2024

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
• Device Model Number: 164.234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 03/04/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Race: Asian