MAUDE Adverse Event Report: ALLOGRAFT, TRIAD; BONE GRAFTING MATERIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Dysphagia/ Odynophagia (1815); Emotional Changes (1831); Fatigue (1849); Headache (1880); Hearing Impairment (1881); Pyrosis/Heartburn (1883); Memory Loss/Impairment (1958); Neuropathy (1983); Pain (1994); Phlebitis (2004); Swelling (2091); Visual Impairment (2138); Myalgia (2238); Arthralgia (2355); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 04/01/2004

Event Type  Injury  

Event Description

Shortly after receiving saline mentor implants breast in 2003, i began having problems and severe neck pain and headaches.I had a discectomy and laminectomy with a triad allograft in 2004 continued experiencing problems with grip and coordination which escalated until i walked with a cane for years.I was healthy before implants but was diagnosed with several different auto immune diseases after implants.Not sure if they are the cause but my children think so and the disease keep accumulating.Original diagnosis was neuropathy which a few years went to graves disease, multiple sclerosis diagnosis.Fibromyalgia, sjogrens, problems with swallowing dysphagia, chronic heartburn, gerd's, cns neuropathy, thrombophlebitis.Brain lesions, positive for 23 kda and 41 kd bands only on lyme test consistently, arthritis and/or swelling of extremities, fatigue, memory problems.Visions, hearing, mood swings, insomnia, changes in nail bed, difficulty walking, breathing difficulties, etc.Breast lesions high risk multiple biopsies, add'l growth of cysts, back pain and burning in back, chest pain, carpal tunnel syndrome or ulnar nerve neuropathy, etc.Dates of use: 15 years.Diagnosis or reason for use: bigger boobs, breast augmentation.Name and strength: im sm rm sal fill mamm prosh, mfr: mentor, lot # 258250 or 58; hi pro sm ru sal fill mamm prosh, mentor, lot # 250926.

• Brand Name: ALLOGRAFT, TRIAD
• Type of Device: BONE GRAFTING MATERIAL
• MDR Report Key: 7582283
• MDR Text Key: 110699811
• Report Number: MW5077705
• Device Sequence Number: 3
• Product Code: NUN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/05/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 36 YR
• Patient Weight: 61