FDA.reportPublic FDA data

MAUDE MDR 4961253

MDR report key
4961253
Report number
3007362683-2015-00011
Event key
0
Event type
3
Date received
2015-07-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
HELEN LEWIS
Address
221 W.PHILADELPHIA ST., STE SUSQUEHANNA COMMERCE CENTER W. YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SURGIGUIDE GUIDEVARIOUS, EBG, LLZ, DZEDENTSPLY IMPLANTS N.V.EBG37504NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-2901. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A SURGIGUIDE WAS USED TO PLACE FOUR IMPLANTS (REGIONS NOT INDICATED). THE IMPLANTS WERE PLACED TOO SHALLOW AND HAD TO BE REMOVED.

N

Patient 1

ACCORDING TO THE AVAILABLE INFORMATION, THE DENTIST CHANGED THE FINAL DESIGN OF THE GUIDE ON THE CAST MODEL TO MODIFY THE POSITION OF THE PLANNED IMPLANT IN REGION 34. IN ADDITION, IT IS STATED THAT HE DID NOT USE THE DRILLS AS ADVISED TO ENLARGE THE APICAL PART OF THE OSTEOTOMY, IN ORDER TO ADAPT THE DESIGN OF THE SITE TO THE LOCAL BONE QUALITY: IN THE MANDIBLE USUALLY THE PREDOMINANT BONE QUALITY IS OF DENSE TYPE, THUS THE ENLARGEMENT OF THE PREPARED BONE IS REQUIRED TO LIMIT THE INSERTION TORQUE TO SUFFICIENT VALUES. THE FACT THAT THE IMPLANTS WERE NOT PLACED INTO THE FINAL POSITION, E.G. AS DEEP AS INTENDED, SEEMS TO BE A SIGN FOR AN INCOMPLETE PREPARATION OF THE IMPLANT SITE. THEREFORE, BECAUSE SURGERY COULD NOT BE COMPLETED AS INTENDED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. IT'S CLEAR THE CHANGES IN THE MOUTH AFTER IMPRESSION WAS MADE CAUSED THE BAD FIT AND THE BAD TRANSFER. THE DENTIST REALIZED AND CORRECTED HIS OWN MISTAKE AND WAS ABLE TO COMPLETE THE SURGERY.