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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number UNK_INS
Device Problem Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Event Description
It was reported that the device caused the handpiece to run when not activated during testing.No patient involvement was reported.
 
Event Description
It was reported that the device caused the handpiece to run when not activated during testing.No patient involvement was reported.
 
Manufacturer Narrative
D9: product not returned.H3 other text : device not returned.
 
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Brand Name
UNKNOWN_INSTRUMENTS_PRODUCT
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key12925535
MDR Text Key281730025
Report Number3015967359-2021-02672
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_INS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/08/2021
Initial Date FDA Received12/03/2021
Supplement Dates Manufacturer Received12/30/2021
Supplement Dates FDA Received01/19/2022
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
Treatment
5407100000,SN (B)(6)
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