FDA.reportPublic FDA data

MAUDE MDR 6731202

MDR report key
6731202
Report number
0001811755-2017-01394
Event key
0
Event type
3
Date of event
2017-06-29
Date received
2017-07-21
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
MR. ZACHARY BAKER
Address
4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
111G IVAS ACCESS CANNULACEMENT, BONE, VERTEBROPLASTYSTRYKER INSTRUMENTS-KALAMAZOOOAR0306330000Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-210

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE BOTTOM HALF OF THE ACCESS CANNULA SHEERED OFF AS THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE PATIENT. THERE WAS NO ATTEMPT TO REMOVE THE DEVICE MATERIAL LEFT BEHIND AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

N

Patient 1

D

Patient 1

IT WAS REPORTED THAT THE BOTTOM HALF OF THE ACCESS CANNULA SHEERED OFF AS THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE PATIENT. THERE WAS NO ATTEMPT TO REMOVE THE DEVICE MATERIAL LEFT BEHIND AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.