CORE * 5400-031-032

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-21 for CORE * 5400-031-032 manufactured by Stryker Instruments.

Event Text Entries

[19552825] Blade would not stay coupled to the hand piece of the stryker drill. Therefore, exchanged blade with a new one.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number1188932
MDR Report Key1188932
Date Received2008-09-21
Date of Report2008-09-21
Date of Event2008-08-28
Report Date2008-09-21
Date Reported to FDA2008-09-21
Date Added to Maude2008-10-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameCORE
Generic NameBLADE, INTRA-ORAL
Product CodeDZH
Date Received2008-09-21
Returned To Mfg2008-09-29
Model Number*
Catalog Number5400-031-032
Lot Number3120101070160178S/0701601
ID Number*
OperatorPHYSICIAN
Device AvailabilityR
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key1222897
ManufacturerSTRYKER INSTRUMENTS
Manufacturer Address4100 E MILHAM AVE. KALAMAZOO MI 49001 US

Device Sequence Number: 2

Brand NameCORE
Generic NameBLADE, INTRA-ORAL
Product CodeDZH
Date Received2008-09-21
Model Number*
Catalog Number5400-031-032
Lot Number31208010722802
ID Number*
Device AvailabilityR
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key1222898
ManufacturerSTRYKER INSTRUMENTS
Manufacturer Address4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US

Patients

Patient NumberTreatmentOutcomeDate
10 2008-09-21
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