FDA.reportPublic FDA data

MAUDE MDR 5768974

MDR report key
5768974
Report number
0001038806-2016-00150
Event key
0
Event type
3
Date of event
2016-06-01
Date received
2016-07-05
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
MS. DANIA PEREZ
Address
4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US
Phone
561-561-5617
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FIXTURE REMOVER SCREW M2.0REMOVER SCREWBIOMET 3IDZAFRS20N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-0501. R

Event Narratives#

D

Patient 1

THE DENTIST REPORTED THAT TWO (2) UNKNOWN IMPLANTS WERE REMOVED DUE TO THE POSITIONING OF THE IMPLANTS. WHILE REMOVING THE IMPLANTS THE FRS20 FIXTURE REMOVER SCREWS FRACTURED INSIDE THE IMPLANTS AND THE FIXTURE REMOVERS. THE DENTIST WAS UNABLE TO DISENGAGE THE SCREWS FROM THE FIXTURE REMOVERS.