MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XTEND; XTEND ANTERIOR CERVICAL PLATE, 1-LEVEL, 16MM

Model Number	161.116
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device unavailable for evaluation.It was reported that one extend anterior cervical plate,1-level, 16mm rotated post-operatively following a 1-level acdf procedure.One xtend plate and one forge cervical allograft spacer were implanted at level c5-c6.The original surgery took place on (b)(6) 2024 and the rotation of the plate was discovered during the patient's standard post-operative visit during the week of (b)(6).The sales representative confirmed via the event evaluation form that there were no adverse effects to the patient.Reached out to the sales representative for additional information.The sales representative stated that a forge cervical allograft spacer was used for the spacer.The holes were drilled with a 14mm drill under power and 4.2mm diameter 14mm length self-tapping variable angle screws were used.Additionally, there are no current plans for a revision surgery.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.If any additional information become available the complaint will be re-evaluated.
Event or Problem Description
It was reported that a xtend anterior cervical plate has rotated inside the patient post operatively.

• Brand Name: XTEND
• Common Device Name: XTEND ANTERIOR CERVICAL PLATE, 1-LEVEL, 16MM
• 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: 20750583
• Report Number: 3004142400-2024-00285
• Device Sequence Number: 11865428
• Product Code: KWQ
• UDI-Device Identifier: 00849044087826
• UDI-Public: 00849044087826
• 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
• 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): 11/21/2024

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: 161.116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/21/2024
• 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: 45 YR
• Patient Sex: Female