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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE MICRO DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO CORE MICRO DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 5100015252
Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 01/15/2020
Event Type  malfunction  
Event Description
The user facility reported that the device overheated and was leaking during a procedure.The patient received a burn from the device.Attempts were made to obtain additional information about the event; no further information has been received.
 
Manufacturer Narrative
Correction: d10, h3 additional info h6 h3 other text : device not returned.
 
Event Description
The user facility reported that the device overheated and was leaking during a procedure.  the patient received a burn from the device.Attempts were made to obtain additional information about the event; no further information has been received.
 
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Brand Name
CORE MICRO DRILL
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10011496
MDR Text Key189590635
Report Number0001811755-2020-01243
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540391803
UDI-Public04546540391803
Combination Product (y/n)N
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5100015252
Device Catalogue Number5400015000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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