FDA.reportPublic FDA data

MAUDE MDR 8586798

MDR report key
8586798
Report number
2939274-2019-57865
Event key
0
Event type
3
Date of event
2019-04-08
Date received
2019-05-07
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
1DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWSINSTR,BENDING OR CONTOURINGWRIGHTS LANE SYNTHES USA PRODUCTS LLCHXP03.130.25003.130.250L657661Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-070

Event Narratives#

N

Patient 1

INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

IT WAS REPORTED THAT ON (B)(6) 2019, A TIP OF THE DEPTH GAUGE BROKE OFF. A NEW DEPTH GAUGE WAS USED FOR THE PROCEDURE. FRAGMENTS WERE GENERATED BUT WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS THIS IS REPORT 1 OF 1 FOR (B)(4).