FDA.reportPublic FDA data

MAUDE MDR 9853886

MDR report key
9853886
Report number
2939274-2020-01364
Event key
0
Event type
3
Date of event
2020-01-01
Date received
2020-03-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGEELEVATORWRIGHTS LANE SYNTHES USA PRODUCTS LLCHTE399.40399.40R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-190

Event Narratives#

N

Patient 1

INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE SHAFT BROKE IN TWO PARTS. THE DISTAL PART WAS DISCARDED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).