MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM DISTAL RADIUS FRACTURE SYSTEM; ANTHEM VOLAR PLATE, DOUBLE ROW, STANDARD, RIGHT, 4 HOLE, SS

Model Number	2171.2314
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plate and screws were returned for evaluation.Observation showed no visible damage to the heads of any of the screws or any defects to the poly holes in the plate.Imaging provided shows the screw heads sitting proud in the mediolateral view.However, since a post-operative image from the initial surgery was not provided, it cannot be confirmed whether the screws have backed out or migrated in position relative to the initial surgery.
Event or Problem Description
It was reported that a revision surgery was done for 2 locking screws backing out of an anthem volar plate 1 month post operatively.

• Brand Name: ANTHEM DISTAL RADIUS FRACTURE SYSTEM
• Common Device Name: ANTHEM VOLAR PLATE, DOUBLE ROW, STANDARD, RIGHT, 4 HOLE, 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 ; 6109301822
• MDR Report Key: 12760254
• Report Number: 3004142400-2021-00212
• Device Sequence Number: 17672254
• Product Code: HWC
• UDI-Device Identifier: 00889095400618
• UDI-Public: 00889095400618
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D299667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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: 2171.2314
• Device Lot Number: BAV524MG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2018
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White