* 2296-31-32

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-03 for * 2296-31-32 manufactured by Stryker Instruments.

Event Text Entries

[384609] While correcting a congenital abnormality of the mandible the saw blade broke into two pieces as the surgeon was using oscillating saw. Both pieces retrieved. Second blade used, also broke into two pieces. Again, both pieces retrieved. No injury to the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW1034266
MDR Report Key564693
Date Received2005-01-05
Date of Report2004-11-24
Date of Event2004-11-19
Date Added to Maude2005-01-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand Name*
Generic NameINTRA-ORAL BLADE
Product CodeDZH
Date Received2004-12-03
Model Number*
Catalog Number2296-31-32
Lot Number010612451V
ID NumberREF# 81922960310320I
Device Expiration Date2006-06-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key554448
ManufacturerSTRYKER INSTRUMENTS
Manufacturer Address* KALAMAZOO MI 49001 US

Device Sequence Number: 2

Brand Name*
Generic NameINTRA-ORAL BLADE
Product CodeDZH
Date Received2004-12-03
Model Number*
Catalog Number2296-31-32
Lot Number01032125IQ
ID Number*
Device Expiration Date2006-06-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key554730
ManufacturerSTRYKER INSTRUMENTS
Manufacturer Address* KALAMAZOO MI 49001 US

Patients

Patient NumberTreatmentOutcomeDate
10 2005-01-05
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