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

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 287391542
• Report Number: 3004142400-2021-00212
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00889095400618
• UDI-Public: 00889095400618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D299667
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2018
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White