MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM PROXIMAL HUMERUS PLATE, RIGHT, 255MM, SS

Model Number 2168.2255

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2020

Event Type  malfunction  

Event Description

It was reported that an anthem proximal humerus plate broke at six months post-operatively.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Post-operative iit)aging shows the plate broke at the level of the proximal fracture.All screws remained engaged in the plate except for the bottom polyaxial calcar screw and the monoaxial calcar screw, which were at the fracture line.The patient's family reported that the patient may have suffered from a fall or experienced other trauma due to non-compliance with weight bearing.It is unclear whether the plate experienced excessive loading or fatigue failure prior to the fracture healing.The exact cause of the reported issue could not be determined.

• Brand Name: ANTHEM
• Type of Device: ANTHEM PROXIMAL HUMERUS PLATE, RIGHT, 255MM, SS
• 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: 18820930
• MDR Text Key: 337348615
• Report Number: 3004142400-2020-00003
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: 2168.2255
• Device Lot Number: BAV551RD
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Race: White