FDA.reportPublic FDA data

MAUDE MDR 2308978

MDR report key
2308978
Report number
3004082685-2011-00004
Event key
0
Event type
3
Date of event
2011-09-15
Date received
2011-10-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STEPHEN SOLOMON
Address
220 S. ORANGE AVE LIVINGSTON NJ 07039 US
Phone
973-973-9735
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMPUDENT STAMILESTONE SCIENTIFICEJISTA-5110R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-10-1801. O

Event Narratives#

D

Patient 1

A COMPUDENT-STA INSTRUMENT WAS USED IN CONJUNCTION WITH A WAND-STA HANDPIECE TO PERFORM A DENTAL ANESTHETIC INJECTION. THE DENTIST PURCHASED A BECTON DICKENSON 30 GAGE 1" NEEDLE AND INSTALLED IT ON THE WAND STA HAND PIECE. THE DENTIST ADMINISTERED MULTIPLE INJECTIONS USING ZORCAIN, MARCAINE AND LIDOCAINE USING A 30G X 1" BD LUER LOCK NEEDLE ATTACHED TO THE WAND STA HAND PIECE. DURING AN INJECTION BETWEEN TEETH #20 AND #21 THE DENTIST HEARD THE NEEDLE SNAP OFF IN THE PTS MOUTH. THE DENTIST REPORTED THAT HE TRIED FEELING FOR THE NEEDLE IN THE PTS MOUTH WITHOUT SUCCESS. THE DENTIST TOOK PANOREX X RAYS TO SEE WHERE THE NEEDLE WAS SITUATED IN THE JAW. PT HAS BEEN REFERRED TO AN ORAL SURGEON.

N

Patient 1

MILESTONE WAS ONLY ABLE TO REVIEW THE NARRATIVE FROM THE DENTIST. NEITHER THE EQUIPMENT OR THE NEEDLE WERE RETURNED FOR EVALUATION. HOWEVER, THE DENTIST DID STATE THE MILESTONE EQUIPMENT DID NOT MALFUNCTION AND OPERATED CORRECTLY. (B)(4).