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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS XL OSCILLIATING SAW UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO TPS XL OSCILLIATING SAW UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100131000
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). Reported events 1 event was reported for this quarter   product return status 1 device was received for evaluation. Evaluation status 1 event was confirmed during testing. 1 device was found to be affected by a missing component. Product disposition the device was repaired and returned to the user facility.   additional information there were no remedial actions taken on this device. This device is not labeled for single-use.
 
Event Description
This report summarizes malfunction event in which the device had a component detach. 1 event had no patient involvement; no patient impact.
 
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Brand NameTPS XL OSCILLIATING SAW
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 Key7714834
MDR Text Key114939951
Report Number0001811755-2018-01231
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
Report Date 07/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100131000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
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

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