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

Model Number	164.234
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004142400-2019-00028
• Device Sequence Number: 3076229
• Product Code: KWQ
• UDI-Device Identifier: 00849044087963
• UDI-Public: 00849044087963
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K092146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 164.234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: Asian