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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). 1 event was reported for this quarter. 1 device was available for evaluation but has not yet been received. There were no remedial actions taken. This device is not labeled for single-use.
 
Event Description
This report summarizes 1 malfunction event in which the device had a broken cutting accessory still attached. There was patient involvement; no patient impact.
 
Event Description
This report summarizes 1 malfunction event in which the device had a broken cutting accessory still attached. There was patient involvement; no patient impact.
 
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.     supplemental rationale corrected data: 1 previously reported events are included in this follow-up record.   product return status: 1 device was not available to stryker for evaluation.   additional information: 1 device is not labeled for single-use. 1 device was not reprocessed and reused. Device not returned.
 
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Brand NameMICRODRILL SERIES STRAIGHT ATTACHMENT
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7467084
MDR Text Key106879470
Report Number0001811755-2018-00912
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100015250
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2017
Is This a Reprocessed and Reused Single-Use Device? No

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