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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL SERIES ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL SERIES ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100015252
Device Problem Disassembly (1168)
Patient Problem No Patient Involvement (2645)
Event Date 09/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).One event was reported for this quarter.One device was received for evaluation.One device evaluation is in progress.There were no remedial actions taken.This device is not labeled for single-use.
 
Event Description
This report summarizes malfunction event in which the device disassembled.One reported event had no 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: manufacturer's evaluation 1 previously reported event is included in this follow-up record.Product return status: 1 device was received for evaluation.Evaluation status: 1 event was not confirmed during testing; the device was found to be within specifications.Additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.
 
Event Description
This report summarizes 1 malfunction event in which the device disassembled.1 reported event had no patient involvement; no patient impact.
 
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Brand Name
MICRO DRILL SERIES ANGLED ATTACHMENT
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7219462
MDR Text Key98520745
Report Number0001811755-2018-00139
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 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5100015252
Was Device Available for Evaluation? No
Date Manufacturer Received09/02/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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