MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XTEND; XTEND ANTERIOR CERVICAL PLATE, 4-LEVEL, 66MM

Model Number	161.466
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device unavailable for evaluation.It was reported that xtend screws migrated post-operatively.The sales representative was contacted and provided additional details: the implanted surgery date occurred on (b)(6) 2024.A 4-level plate (161.466) was used from c3-c7.The surgeon bent the plate to better fit the patients anatomy.Midas was used for the screw preparation and 4.2mm, variable angle, self-drilling, 14mm screws (161.014) were inserted into the plate.The surgeon then blocked the set screws.The revision surgery occurred on (b)(6) 2024.After inspecting the plate and screw, the sales representative and surgeon determined that the set screw was not completely blocking the bone screw hole.There was no damage to the set screw.Leaving the set screw unblocked would have allowed the bone screw to migrate anteriorly.The migrating screw was removed, and the plate was left in the patient because the set screw was undamaged.To avoid the previous screw hole trajectory, a new hole was drilled, and a 4.6mm variable angle, self-tapping, 16mm screw (171.316) was inserted.The surgeon ensured that the screws were blocked.There were no adverse effects to the patient.The determination is that the cause is traced to user.
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, 4-LEVEL, 66MM
• 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: 19734522
• Report Number: 3004142400-2024-00145
• Device Sequence Number: 15238100
• Product Code: KWQ
• UDI-Device Identifier: 00849044088250
• UDI-Public: 00849044088250
• 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: 161.466
• 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: 50 YR
• Patient Sex: Female