FDA.reportPublic FDA data

MAUDE MDR 30587

MDR report key
30587
Report number
30587
Event key
0
Event type
3
Date of event
1995-11-16
Date received
1996-01-31
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1JOKER PERIOSTEAL ELEVATORUNKNOWNGEGNANY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11996-01-3101. H

Event Narratives#

D

Patient 1

DURING SURGERY, THE TIP OF THE PERIOSTAL ELEVATOR BROKE OFF. X-RAY REVEALED TIP IN THE OPEN WOUND. TIP WAS REMOVED PRIOR TO CLOSURE. NO ADVERSE OUTCOMES DUE TO THIS EVENT WERE OBSERVED BY THE PT'S PHYSICIAN.