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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2020
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: 11 events were reported for this quarter. Product return status: 3 devices were received. 8 device investigation types have not yet been determined. Event confirmation status: 3 reported events were not confirmed. Evaluation results: 2 devices were found to be affected by internal corrosion. 1 device had no problem found. 11 devices were not labeled for single-use. 11 devices were not reprocessed or reused.
 
Event Description
This report summarizes 11 malfunction events in which the device reportedly overheated. 9 events had no patient involvement; no patient impact. 2 events had patient involvement; no patient impact.
 
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Brand NameMICRODRILL STRAIGHT ATTACHMENT
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10331477
MDR Text Key200620927
Report Number0001811755-2020-01970
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540380272
UDI-Public04546540380272
Combination Product (y/n)N
Number of Events Reported13
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5100015250
Device Catalogue Number5100015250
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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