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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO OSCILLATING SAW; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO OSCILLATING SAW; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100031000
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One device was not available to stryker for evaluation.There were no remedial actions taken.This device is not labeled for single-use.Device discarded.
 
Event Description
This report summarizes 1 malfunction event in which the device disassembled.One reported event had no patient involvement; no patient impact.
 
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Brand Name
TPS MICRO OSCILLATING SAW
Type of Device
UNIT, 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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6747980
MDR Text Key81309945
Report Number0001811755-2017-01428
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 Other
Type of Report Initial
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5100031000
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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