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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 06/24/2019
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 9 events were reported for this quarter.Product return status: 6 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status: 5 reported events were confirmed.1 reported events were not confirmed.Evaluation results: 4 devices were found to be affected by internal corrosion.1 device was found to be seized.1 device was found to be affected by shattered bearings.Additional information: 9 devices were not labeled for single-use.9 devices were not reprocessed and reused.
 
Event Description
This report summarizes 9 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.2 events had no known impact or consequences to the patient.1 event had the patient receive a burn.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale 9 previously reported events are included in this follow-up record.Product return status 6 devices were received.3 devices were not available for evaluation.Event confirmation status 5 reported events were confirmed.1 reported event was not confirmed.Evaluation results 4 devices were found to be affected by corroded bearings.1 device was found to be affected by shattered bearings.1 device was found to be seized.
 
Event Description
This report summarizes 9 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.2 events had no known impact or consequences to the patient.1 event had the patient receive a burn.
 
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Brand Name
MICRODRILL SERIES STRAIGHT ATTACHMENT
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8816403
MDR Text Key152248406
Report Number0001811755-2019-02433
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540380272
UDI-Public04546540380272
Combination Product (y/n)N
Number of Events Reported9
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5100015250
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/24/2019
Initial Date FDA Received07/23/2019
Supplement Dates Manufacturer Received06/24/2019
Supplement Dates FDA Received10/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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