MAUDE Adverse Event Report: Globus Medical, Inc. ANTHEM; Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-steril

Model Number	1170.9727
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(610)930-1800
• MDR Report Key: 50763544
• Report Number: 3004142400-2026-00198
• Device Sequence Number: 15806275
• Product Code: HRS
• UDI-Device Identifier: 00193982093143
• UDI-Public: 00193982093143
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K202496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 1170.9727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male
• Patient Weight: 270 LB
• Patient Race: White