1.6MM CROSS-CUT FISSURE CARBIDE BUR 2296101316

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-27 for 1.6MM CROSS-CUT FISSURE CARBIDE BUR 2296101316 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[118305612] A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[118305613] It was reported that during a dental extraction surgery, the bur broke at the cutting end. It was also reported that there were no adverse consequences and no delays as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2018-01617
MDR Report Key7818622
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-08-27
Date of Report2018-10-10
Date of Event2018-07-31
Date Mfgr Received2018-10-05
Device Manufacturer Date2018-02-12
Date Added to Maude2018-08-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. UNA BARRY
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer PostalNA
Manufacturer Phone214532900
Manufacturer G1STRYKER INSTRUMENTS-IRELAND
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1.6MM CROSS-CUT FISSURE CARBIDE BUR
Generic NameBUR, DENTAL
Product CodeEJL
Date Received2018-08-27
Returned To Mfg2018-08-21
Catalog Number2296101316
Lot Number18043017
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-27

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