FDA.reportPublic FDA data

MAUDE MDR 5906114

MDR report key
5906114
Report number
0001038806-2016-00216
Event key
0
Event type
3
Date of event
2016-08-09
Date received
2016-08-26
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 M 2.0IMPLANT REMOVAL SCREWNEOBIOTECHDZAFRS20N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-2601. R

Event Narratives#

D

Patient 1

THE DENTIST REPORTED THAT DURING THE PROCEDURE TO REMOVE AN UNKNOWN IMPLANT THE FIXTURE REMOVER SCREW (FRS20) FRACTURED AND STUCK INSIDE THE FIXTURE REMOVER (FR415). THE DENTIST COMPLETED THE REMOVAL OF THE IMPLANT SURGICALLY.

N

Patient 1

D

Patient 1

THE DENTIST REPORTED THAT DURING THE PROCEDURE TO REMOVE A NON-ZIMMER BIOMET IMPLANT THE FIXTURE REMOVER SCREW (FRS20) FRACTURED AND BROKE OFF INSIDE THE IMPLANT. THE FRACTURED PORTION OF THE REMOVER SCREW BECAME STUCK IN THE FIXTURE REMOVER (FR415). THE DENTIST COMPLETED THE REMOVAL OF THE IMPLANT SURGICALLY.