FDA.reportPublic FDA data

MAUDE MDR 9833064

MDR report key
9833064
Report number
1030489-2020-00305
Event key
0
Event type
3
Date of event
2020-02-13
Date received
2020-03-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STACIE ZIEMBA
Address
1800 PYRAMID PLACE MEMPHIS TN 38132 US
Phone
901-901-9013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIT, DRILLBIT, DRILLMEDTRONIC SOFAMOR DANEK USA, INCHTWNA873-007NG18H019N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-140

Event Narratives#

N

Patient 1

PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ODONTOID PROCESS FRACTURE; AND ANTERIOR SCREW FIXATION AT C2. INTRA-OP, THE DRILL BIT BROKE AT THE TIME OF CREATING THE PILOT HOLE. AFTER THE GUIDE WIRE WAS PLACED USING THE GUIDE, THE DRILL BIT WAS CONNECTED WITH THE HOSPITAL POWER. THEN DRILLING WAS PERFORMED WHILE CHECKING THE IMAGE. BONE QUALITY DID NOT SEEM SO HARD. WHEN THE DRILL WAS PULLED BACK AFTER ADVANCING TO THE DESIRED DEPTH, IT WAS NOTICED THAT THE DRILL TIP BROKE OFF AT THE BASE OF THE BLADE; AND THE BROKEN TIP WAS REMAINING IN THE VERTEBRAL BODY. IT WAS CONFIRMED THAT THE DRILL TIP PROTRUDED ABOUT 5 MM AHEAD OF THE VERTEBRAL BODY UNDER THE IMAGE AND VISUAL OBSERVATION. SKIN INCISION WAS WIDENED A LITTLE AND THE BROKEN TIP WAS REMOVED FROM THE PATIENT. IT WAS CONFIRMED BY IMAGE THAT THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT BODY. LATER, THE GUIDE WIRE WAS INSERTED, PLACED AND SCREW INSERTION WAS PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.