MAUDE MDR 1069170

MDR report key
1069170
Report number
MW5007507
Event key
0
Event type
3
Date of event
2007-10-23
Date received
2008-06-20
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KODAKE SPEED PANORAMIC FILMKODAKIXWNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-06-2001. O

Event Narratives#

D

Patient 1

PATIENT SCHEDULED TO HAVE TWO UPPER LEFT AND RIGHT, AND THE LOWER RIGHT WISDOM TEETH EXTRACTED UNDER MODERATE SEDATION. THE FILM BASED RADIOGRAPH WAS ORIENTED INCORRECTLY ON THE VIEW WHICH RESULTED IN THE SURGICAL EXPLORATION OF THE WRONG AREA. UF-UNCONTROLLABLE FACTORS FILM-BASED PANORAMIC FILM MUST BE INVERTED ON THE VIEW BOX TO BE ORIENTED CORRECTLY. THE PANORAMIC FILM IS MARKED WITH AN "L" OR "R" IN THE APPROPRIATE CORNER, WHEN THE FILM IS PROPERLY PLACED ON THE VIEW BOX, THE "L" AND "R" ARE BACKWARDS. THIS HAS BEEN ACCEPTED AS AN INDUSTRY NORM BY THE PROFESSIONAL DENTAL COMMUNITY AND HAS BEEN ADDRESSED THROUGH CONTINUAL TRAINING AND ENSURING COMPLIANCE WITH UNIVERSAL PROTOCOL REQUIREMENTS. COULD THE WORDS -FRONT- BE PLACED ON THE FILM OR THE "L" AND "R" BE UNIVERSALLY CHANGED, SO THAT IT IS LOGICAL TO THE USER? DIAGNOSIS OR REASON FOR USE: X-RAYS FOR WISDOM TEETH EXTRACTION.