MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; INTERNAL ORTHOPAEDIC FIXATION SYSTEM, PLATE/SCREW, NON-BIOABSORBABLE, NON-STERIL

Model Number	2195.2017
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient initially experienced a motor vehicle collision which caused both femurs to fracture and require orif plating.The patient had lateral and medial comminution on both femurs.The patient's left femur was fixed with a lateral plate and medial bone graft, while the right side was only fixed with the lateral locking plate that was removed due to the screw breakages.It was reported that the patient is an avid smoker and still had a non-union and signs of delayed healing up to the removal of the hardware.The plate was not returned for evaluation, therefore, the dhr and ncmr record could not be evaluated.Should the plate be returned, the investigation shall be reopened.This evaluation determined that this failure was within expected risk and occurrence; therefore, no further actions will be taken at this time.
Event or Problem Description
It was reported that when patient followed up imaging showed broken distal 4.5mm locking screws.The original date of surgery was (b)(6) 2025.The original fracture was caused by a car accident.The patient reported no event prior to screws breaking.The surgeon removed all of our hardware and replaced with a synthes plate.The patient was not infected.

• Brand Name: ANTHEM
• Common Device Name: INTERNAL ORTHOPAEDIC FIXATION SYSTEM, PLATE/SCREW, NON-BIOABSORBABLE, NON-STERIL
• 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: 23829521
• Report Number: 3004142400-2025-00291
• Device Sequence Number: 17413342
• Product Code: HRS
• UDI-Device Identifier: 00193982017248
• UDI-Public: 00193982017248
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K213591
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 2195.2017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/17/2025
• 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 Age: 25 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic