FDA.reportPublic FDA data

MAUDE MDR 2367700

MDR report key
2367700
Report number
1060818-2011-00002
Event key
0
Event type
3
Date of event
2011-03-22
Date received
2011-04-21
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
MRS. DONNA HOGAN
Address
2300 RIVERCHASE CENTER BIRMINGHAM AL 35244 US
Phone
866-866-8668
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOHORIZONS PRAINTERNAL ABUTMENT-LEVEL DRIVER, RATCHET, PRODUCT CODE: DZNBIOHORIZONS IMPLANT SYSTEMS, INC.DZEPRAPRAUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-2101. O

Event Narratives#

D

Patient 1

CLINICIAN WAS USING PRA (ABUTMENT-LEVEL DRIVER, RATCHET) TO PLACE IMPLANT; THE PRA DISENGATED FROM THE RATCHET AND THE PT ASPIRATED THE PRA. IT WAS REPORTED THAT SURGERY WAS REQUIRED TO REMOVE THE PRA FROM THE PT. NO PRODUCT WILL BE RETURNED TO BIOHORIZONS FOR INSPECTION.

N

Patient 1

THE CLINICIAN REPORTED THAT THE PRA DISENGAGED FROM THE RATCHET AND WAS ASPIRATED, AND THAT SURGERY WAS REQUIRED TO REMOVE THE ASPIRATED PRA; NO FURTHER INFO HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT. INSPECTION OF THE ACTUAL PRA INSTRUMENT INVOLVED WAS NOT POSSIBLE AS THE PRA HAD NOT BEEN RETURNED AS OF THE DATE OF THIS REPORT.