FDA.reportPublic FDA data

MAUDE MDR 8448198

MDR report key
8448198
Report number
3012787974-2019-80001
Event key
0
Event type
3
Date of event
2019-02-20
Date received
2019-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DR. THOMAS CLAIBORNE
Address
2800 BISCAYNE BLVD. SUITE 600 MIAMI FL 33137 US
Phone
855-855-8559
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEOCIS GUIDANCE SYSTEMBONE CUTTING INSTRUMENT AND ACCESSORIESNEOCIS INC.PLVGEN 1NANAY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2501. R

Event Narratives#

N

Patient 1

THE DRILL AND DRILL MOTOR ARE REUSABLE PARTS. RIGIDITY INSPECTIONS WERE PREVIOUSLY ON LABEL. NEOCIS IMPLEMENTED FIELD NOTIFICATION ON 12-MAR-2019 TO REMIND USERS AND FIELD PERSONNEL TO INSPECT THE DRILL-TO-DRILL MOTOR CONNECTION FOR RIGIDITY, AS PREVIOUSLY LABELED. LOOSE DRILLS SHOULD BE REMOVED FROM SERVICE AND REPLACED WITH NEW DRILLS. DRILL FACE CALIBRATION IS PERFORMED PRIOR TO EACH CASE TO HELP ENSURE OSTEOTOMY ACCURACY. (B)(4).

D

Patient 1

GUIDED OSTEOTOMY DEVIATED FROM THE PLAN AND RESULTED IN A BREACH OF THE BUCCAL CORTICAL PLATE. DEFECT REPAIRED WITH XENOGRAFT MEMBRANE AND BONE. PLAN DEVIATION CAUSED BY ROTATION OF THE DRILL HANDPIECE AT THE DRILL MOTOR INTERFACE. THE DRILL HANDPIECE STABILIZATION PIN WAS FOUND TO BE LOOSE.