FDA.reportPublic FDA data

MAUDE MDR 5923696

MDR report key
5923696
Report number
3007362683-2016-00009
Event key
0
Event type
3
Date received
2016-09-01
Adverse event
3
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.LLZNA37501NAY R
2DZEY
3EBGY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-010

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 IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

D

Patient 1

IT WAS REPORTED THAT A SURGIGUIDE WAS USED TO PLACE A DENTAL IMPLANT. THE IMPLANT TRANSFER WAS TOO SHALLOW AND THE GUIDE DID NOT FIT. THE CLINICIAN REPORTED THAT ADDITIONAL STEPS DURING THE SURGERY WERE NEEDED TO PLACE THE IMPLANT DEEPER. A SECOND CORRECTIVE SURGERY WAS NOT NEEDED.

N

Patient 1

THE PRODUCTS HAVE BEEN RETURNED AND INVESTIGATION SHOWS THAT THE PRODUCT HAS BEEN MANUFACTURED ACCORDING TO OUR STANDARDS. THE FIT ON THE MODEL WAS GOOD, THE PRODUCT HAS BEEN FINISHED CORRECTLY, THE MATCHING OF THE DIGITAL PLASTER MODEL WAS GOOD AS WELL AS THE EXTRACTIONS PERFORMED ON THE STONE MODEL.