FDA.reportPublic FDA data

MAUDE MDR 5799067

MDR report key
5799067
Report number
3007362683-2016-00006
Event key
0
Event type
3
Date of event
2016-05-31
Date received
2016-07-15
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. HELEN LEWIS
Address
221 W. PHILADELPHIA ST. SUITE 60W YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SURGIGUIDESYSTEM, IMAGE PROCESSING, RADIOLOGICALDENTSPLY IMPLANTS N.V.LLZNA37501NA R
2DZE
3EBG

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-150

Event Narratives#

N

Patient 1

THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS EVALUATED AND FOUND TO MEET SPECIFICATION. THE CUSTOMER PROVIDED AN OUTDATED MODEL FOR THE GUIDE DESIGN.

D

Patient 1

IT WAS REPORTED THAT A SURGIGUIDE DID NOT PROPERLY FIT IN A PATIENT'S MOUTH. THE DENTAL IMPLANT PLACEMENT SURGERY HAS BEEN DELAYED.