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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100015270
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/31/2019
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 or reused.
 
Event Description
This report summarizes 1 malfunction event in which the device fractured. 1 event had patient involvement; no patient impact.
 
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Brand NameMD SERIES LONG STRAIGHT 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 Key9636735
MDR Text Key177374667
Report Number0001811755-2020-00218
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540380289
UDI-Public04546540380289
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 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5100015270
Device Catalogue Number5100015270
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 Received12/31/2019
Was Device Evaluated by Manufacturer? No
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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