FDA Adverse Event Other Summary report: N

NOBELREPLACE TAPERED GROOVY 6.0 6X10MM

MDR report key: 1126043 · Received August 19, 2008

Report

Report Number
MW5008022
Event Type
Other
Date Received
August 19, 2008
Report Date
August 15, 2008
Manufacturer
NOBEL BIOCARE USA, LLC
Product Code
DZE
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

POSSIBLE PARESTHESIA: THE DEFINITION FROM NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKES PROVIDES A GREAT EXAMPLE OF MY EXPERIENCES. PARESTHESIA IS INCLUDED IN THE FOLLOWING FDA GUIDANCE DOCUMENT AS WELL: CLASS II SPECIAL CONTROLS GUIDANCE DOCUMENT: ROOT-FORM ENDOSSEOUS DENTAL IMPLANTS AND ENDOSSEOUS DENTAL IMPLANT ABUTMENTS. SPECIFICALLY, I AM EXPERIENCING ITCHING, BURNING, SKIN CRAWLING, AND TINGLING SENSATIONS THROUGH OUT MY BODY. THE NIH DEFINITION IS AS FOLLOWS: PARESTHESIA REFERS TO A BURNING OR PRICKLING SENSATION THAT IS USUALLY FELT IN THE HANDS, ARMS, LEGS, OR FEET, BUT CAN ALSO OCCUR IN OTHER PARTS OF THE BODY. THE SENSATION, WHICH HAPPENS WITHOUT WARNING, IS USUALLY PAINLESS AND DESCRIBED AS TINGLING OR NUMBNESS, SKIN CRAWLING, OR ITCHING. I EXPERIENCE THE SYMPTOMS ON MY FACE, TORSO, ARMS, LEGS, FEET, HANDS, SCALP, ETC. ALL DERMATOMES SEEM TO BE AFFECTED. MORE RECENTLY, I HAVE EXPERIENCED OPPOSITE-SIDE JAW PAIN AS WELL. I REPORTED THIS PROBLEM TO NOBEL BIOCARE AND THE DR. A NOBEL BIOCARE CONSULTANT CONTACTED ME THE WEEK OF 08/11/08 AND STATED NOBEL BIOCARE HAD NEVER HEARD OF SUCH A CONDITION BEING CAUSED BY DENTAL IMPLANTS. AS A SIDE NOTE, I HAD REPORTED THE INCIDENT DURING THE WINTER AS WELL AND WAS TOLD THE SAME. PERSONALLY, I WAS WONDERING IF THE METAL WAS BEING AFFECTED BY A LOW-LEVEL VIBRATIONS WHICH MAY HAVE CAUSED REFERRED SENSATION VIA NERVE PATHWAYS. SINCE I HAVE NOT HAD A "CROWN", OR "FALSE-TOOTH" ATTACHED, I DIDN'T KNOW IF THAT WOULD AFFECT THE SENSATIONS. IN PARTICULAR, I WAS HOPING THE IMPLANT WOULD NOT HAVE TO BE REMOVED SINCE IT MAY AFFECT THE STRUCTURAL INTEGRITY OF THE JAW. ACTUALLY, ANY VIBRATION FREQUENCY THAT MAY RESONATE WITH THE TITANIUM IMPLANT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NOBELREPLACE TAPERED GROOVY 6.0 6X10MM DENTAL IMPLANT WITH HEALING ABUTMENT DZE NOBEL BIOCARE USA, LLC 391419

Patients

Seq Age Sex Outcome Treatment
1 39 YR Other