FDA.reportPublic FDA data

MAUDE MDR 6963520

MDR report key
6963520
Report number
9680938-2017-10138
Event key
0
Event type
3
Date received
2017-10-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHAEL COTE
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGEELEVATORSYNTHES TUTTLINGENHTE399.486009Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-190

Event Narratives#

N

Patient 1

NO PATIENT INVOLVEMENT REPORTED. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW DHR HAS BEEN REQUESTED. 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 THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT A PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE HAS A BROKEN HANDLE. THERE IS NO PATIENT/PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).