PROPLAST MALAR IMPLANTS UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-02 for PROPLAST MALAR IMPLANTS UNK manufactured by Vitek, Inc..

Event Text Entries

[1027839] 1990: to correct a previous overbite, a leforte i maxillary osteotomy, genioplasty and insertion of "six mm proplast hudroxy apatite implants were placed in the right and left infraorbital rim areas. The implants were held in position using a single 12mm titanium screw on both the right and left sides". The surgical procedure was performed by medical center, in 2004 for eight months : as a result of swelling around the left eye, i visited one of the original surgeons, who inserted the proplast implants. The original surgeon said there was nothing wrong with the implant on the left side, said he never had a problem with these type of implants and said i had sinusitus and prescribed an antibiotic. From 2004 to 2007: i experienced severe cranial facial pain, fatigue, congestion, stiffness, soreness, loss of hearing, raspy voice and swelling around the left and right facial cheek areas. Doctors and hospitals treated the headaches with pain killers and treated the congestion with antibiotics. As a result of my ongoing problems, beginning of 2004 to mid 2007, in 2007 another dr, at the medical center removed the left cheek implant, which was completely fragmented. Quoting from dr. Operative notes- "the wire removed with the screw and it is to be noted that the cheek implant had a rod into the buttress area and there several holes that again were not associated with the osteotomy. Also, the material had several very small branches that were tenuous. We did our best to preserve these. There was very little intact nerve upon entry. Also, it is to be noted that we previously been told by correspondence that this is a porex implant and to my eye and certainly based on my experience, this represented a "proplast" implant. At this point, we meticulously debrided this down to the bone and also the areas of perforation on the underside of the implant. There were areas of blackened tissue that were very rubbery, inflammatory and possibly foreign body giant cell reaction". In 2008, dr removed the right proplast cheek implant. For eleven months in 2008: i continue to suffer from the effects of proplast. I underwent a third invasive surgery -septoplasty and turbinectomies- six days later related to my cranial and facial headaches that are related to the insertion to proplast into my body in 1990. Dates of use: 1990 - 2008. Diagnosis or reason for use: augmentation infraorbital rims left and right side. Event abated: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5009158
MDR Report Key1260675
Date Received2008-12-02
Date of Report2008-12-02
Date of Event1990-11-01
Date Added to Maude2009-03-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePROPLAST
Generic NameHUDROXY APATITE -MALAR, BLOCKS, CUSTOM- FACIAL
Product CodeLZK
Date Received2008-12-02
Model NumberMALAR IMPLANTS
Catalog NumberUNK
Lot NumberUNK
ID NumberPTFE, CAS #9002-84-0
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerVITEK, INC.
Manufacturer AddressHOUSTON TX US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit 2008-12-02

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