MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XTEND; XTEND ANTERIOR CERVICAL PLATE, 3-LEVEL, 54MM

Model Number	161.354
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned device found one set screw is in the locked position.This set screw is on an end level and corresponds to the position of the screw which was backed out of the plate.There is damage to the set screw which relates to the position of the screw head.This damage can caused by angulating the screw farther than the allowable range during implantation, or the screw backing out of the plate and deforming the set screw in the process.Based upon the x-rays provided, the screws do not appear to have a steep angle but since settling may have occurred since the primary surgery, it is possible the screws were implanted on a higher angle.While the exact cause of the reported issue cannot be determined, it's possible that improper screw angle may have contributed.
Event or Problem Description
It was reported during the six week post-opererative follow-up, that one screw backed out of the xtend plate.Revision surgery was required.

• Brand Name: XTEND
• Common Device Name: XTEND ANTERIOR CERVICAL PLATE, 3-LEVEL, 54MM
• 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: 18832282
• Report Number: 3004142400-2019-00024
• Device Sequence Number: 18112653
• Product Code: KWQ
• UDI-Device Identifier: 00849044088168
• UDI-Public: 00849044088168
• 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: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 161.354
• Device Lot Number: FCU171FC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2017
• 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: 42 YR
• Patient Sex: Male
• Patient Race: Black Or African American