FDA.reportPublic FDA data

MAUDE MDR 1504331

MDR report key
1504331
Report number
1811755-2009-00538
Event key
0
Event type
3
Date of event
2009-08-20
Date received
2009-09-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
GREGORY GOHL
Address
4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REPAIR CMDII IMPACTION DRILLSURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMSTRYKER INSTRUMENTS KALAMAZOODZA2296300000RN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-09-150

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE DOCTOR BEGAN USING THE DEVICE TO REMOVE WISDOM TEETH, BUT AS THE PROCEDURE CONTINUED, THE HANDPIECE BECAME INCREASINGLY HOTTER IN HIS OWN HAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WAS NO REPORTED PT OR USER INJURY.

N

Patient 1

THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DRILL, AND A F/U REPORT WILL BE SUBMITTED.