MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM VOLAR PLATE, DOUBLE ROW, STANDARD, LEFT, 3 HOLE, SS

Model Number	2171.1313
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device or any x-rays could be provided for evaluation.A partial tendon rupture is evident from the images provided.The surgeon stated that the screws were not prominent.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that an anthem volar plate was removed due to the rupture of the patient's fpl.

• Brand Name: ANTHEM
• Common Device Name: ANTHEM VOLAR PLATE, DOUBLE ROW, STANDARD, LEFT, 3 HOLE, SS
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10575547
• Report Number: 3004142400-2020-00111
• Device Sequence Number: 1270382
• Product Code: HWC
• UDI-Device Identifier: 00889095400359
• UDI-Public: 00889095400359
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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): 09/21/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2171.1313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other