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MAUDE Adverse Event Report: STRYKER BUR
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STRYKER BUR
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Model Number
OVAL BUR
Device Problem
Break (1069)
Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date
05/05/2014
Event Type
Injury
Event Description
Bur broke during procedure.
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Brand Name
BUR
Type of Device
BUR
Manufacturer
(Section D)
STRYKER
kalamazoo 49001
MDR Report Key
3840172
MDR Text Key
4613589
Report Number
MW5036323
Device Sequence Number
1
Product Code
HTT
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Nurse
Type of Report
Initial
Report Date
05/22/2014
1
Device was Involved in the Event
1
Patient was Involved in the Event
Date FDA Received
05/23/2014
Is this an Adverse Event Report?
No
Is this a Product Problem Report?
Yes
Device Operator
Health Professional
Device Model Number
OVAL BUR
Device Catalogue Number
277-10-62
Is the Reporter a Health Professional?
Yes
Is This a Reprocessed and Reused Single-Use Device?
No
Patient Sequence Number
1
Patient Outcome(s)
Required Intervention;
Patient Age
61 YR
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