MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XTEND; XTEND ANTERIOR CERVICAL PLATE, 3-LEVEL, 48MM

Model Number	161.348
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.It was reported that screws are backing out of the xtend plate post-operatively.The implanted surgery date occurred on (b)(6) 2024.A 3-level plate was used from c3-c6.Post-operative imaging showed that the screws at the bottom of the construct (c6 screws) had migrated anteriority.There are no plans to revise at this time.There will no adverse effects to the patient.No determinations can be made for the cause of the reported issue.
Event or Problem Description
It was reported that screws are backing out of the xtend plate post-operatively.

• Brand Name: XTEND
• Common Device Name: XTEND ANTERIOR CERVICAL PLATE, 3-LEVEL, 48MM
• 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: 19734509
• Report Number: 3004142400-2024-00144
• Device Sequence Number: 7137299
• Product Code: KWQ
• UDI-Device Identifier: 00849044088144
• UDI-Public: 00849044088144
• 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: 2024
• 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): 07/12/2024

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: 161.348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/12/2024
• 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: 61 YR
• Patient Sex: Female