MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XTEND ANTERIOR CERVICAL PLATE SYSTEM; XTEND ANTERIOR CERVICAL PLATE, 3-LEVEL, 51MM

Model Number	161.351
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to replace screws that were backing out of the xtend anterior cervical plate post-operatively.
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that the two most inferior xtend 4.2mm x 16mm self-drilling, fixed angle screws backed out of an xtend anterior cervical plate, 3-level, 51mm following a 3-level acdf procedure.The original surgery took place on (b)(6) 2025 and the revision to remove the screws that backed out took place on (b)(6) 2025.Hedron c spacers were implanted into the disc spaces.Additionally, a burr was used to break through the cortical bone prior to the screws being inserted into the plate.It was confirmed that there were no adverse effects to the patient.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.No determinations could be made as to the cause of the reported issue.

• Brand Name: XTEND ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: XTEND ANTERIOR CERVICAL PLATE, 3-LEVEL, 51MM
• 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: 22013644
• Report Number: 3004142400-2025-00103
• Device Sequence Number: 7985458
• Product Code: KWQ
• UDI-Device Identifier: 00849044088151
• UDI-Public: 00849044088151
• 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: 2025
• Device Explanted Year: 2025
• 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): 05/08/2025

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: 161.351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/13/2025
• 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 Sex: Male