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

Model Number	2186.0211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An anthem stainless steel anterior lateral shallow plate was broken post-operatively about 4 months after implantation and required surgery to remove it.The implantation occurred in (b)(6) 2025, and the date of removal was (b)(6) 2025.The plate broke at the location of the triangular suture holes between two screw holes in the plate and it was reported that the patient presented with delayed fracture healing.It was reported that the patient was transferred for a right proximal femoral replacement for a failed hip fracture after the initial clavicle plate implantation and was utilizing their upper body to weight bear with a walker during recovery.The patient also had a history of breast cancer, hypothyroidism, and was using hormone therapy medication.The expected delayed in fracture healing, in addition to weight-bearing through their upper extremity is likely to have stressed the implant and caused the plate failure.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 a plate broke after implanting in patient a few months prior.

• 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: 23719791
• Report Number: 3004142400-2025-00288
• Device Sequence Number: 8460270
• Product Code: HRS
• UDI-Device Identifier: 00889095959482
• UDI-Public: 00889095959482
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173166
• 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): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2186.0211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/04/2025
• 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 Sex: Unknown