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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
Model Number 5100015252
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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: 1 event was reported for this quarter. Product return status: 1 device investigation type has not yet been determined. Additional information: 1 device was not labeled for single-use. 1 device was not reprocessed and reused.
 
Event Description
This report summarizes 1 malfunction event in which the device had a component detach. 1 event had no patient involvement; no patient impact.
 
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Brand NameMICRO DRILL SERIES ANGLED ATTACHMENT
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8816408
MDR Text Key152089212
Report Number0001811755-2019-02477
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5100015252
Device Catalogue Number5100015252
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
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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