MAUDE Adverse Event Report: VITEK PROPLAST; IMPLANT, MALAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Death (1802); High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Date 01/01/1982

Event Type  Death  

Event Description

The pt had the vitek proplast implant and was at (b)(6) in (b)(6) 2018 (5' 6 1/2").She was unable to find anymore to help her treat her pain.Her blood pressure was at 248/123 due to pain.She had 38 facial and jaw surgeries to try to fix the proplast damage.She also had 32 others to fix her crumbling body from the teflon fragments.She had horrendous pain throughout her face, jaw and body; 13 of the proplast implants broke / ruptured inside her.Her pain dr abandoned her as he said she was too complicated.He cut her off all pain and muscle relaxers.She was unable to eat as she developed strictures in her esophagus.Water would not go down either.She would have her throat dilated every few months.Her hands were not able to be used as she developed severe arthritis everywhere.Proplast ruined her life.She had the first surgery at the age of (b)(6) and she died (b)(6).

• Brand Name: VITEK PROPLAST
• Type of Device: IMPLANT, MALAR
• MDR Report Key: 8068997
• MDR Text Key: 127141237
• Report Number: MW5081187
• Device Sequence Number: 1
• Product Code: LZK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 37