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

Model Number	7206.1070
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a screw broke about 7 months after implantation and required surgery to remove.The implantation occurred on (b)(6) 2025 and had to be removed on (b)(6) 2026 due to several distal 4.5mm locking screw breakages and cancellous screws backing out.The screws broke at the neck of the screw, leaving the screw heads in the plate.This event is associated with the three (3) other distal screws that were broken, the cancellous screw that backed out, the non-locking screws, and the plate, which all were removed from the patient.The patient initially presented with a distal femur non-union and underwent part one of a masquelet surgery, which consisted of an antibiotic loaded cement spacer, an anthem distal femur plate and screws, and independent lag screws.The patient did not return for part two of the masquelet surgery, which is typically performed 4-8 weeks after the initial procedure, and involves removing the cement spacer and replacing it with bone graft.Failure to carry out the second stage of the procedure in the suggested timeframe comes with a high risk of failed bone union, hardware failure, and infection of the spacer.The patient also has a bmi that is a contraindication of the anthem distal femur system.The combination of these factors is very likely the reason for the screw breakages and backout.They confirmed that the plate and screws that were loaded in the plate were removed from the patient and disposed of appropriately.The independent broken lag screws were left in the patient as the surgeon did not think it would have any adverse effect on the patient.The surgeon used a retrograde nail with a lateral locking washer plate in the revision surgery.The screw was not returned for evaluation, therefore, the dhr and ncmr record could not be evaluated.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that the patient had original surgery for a left distal femur fracture (b)(6) 2025.The patient was having a revision surgery done due to a nonunion.The distal locking screws in the plate sheared off and the cancellous screw backed out.There were also 4 lag screws in the patient and 2 of the were broken as well.The surgeon did not remove any of the lag screws as he did not feel it would have any adverse effect to the patient.The surgeon took out the plate and all the screws for the plate, used the synthes ria and then put in one of our 12x360 retrograde nail and left retrograde locking washer plate.During today's surgery some samples were sent to pathology and one of the samples did come back with a neutrophils range of 5-10 which indicates a possible infection.After the original surgery on (b)(6) 2025, patient did not return for part 2 of masquelet.

• 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: 25221674
• Report Number: 3004142400-2026-00104
• Device Sequence Number: 13262138
• Product Code: HRS
• UDI-Device Identifier: 00193982175191
• UDI-Public: 00193982175191
• 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
• 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): 05/19/2026

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: 7206.1070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/19/2026
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 152 KG
• Patient Race: White