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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMALL POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO SMALL POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-012-000
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/21/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the short pointer broke off at the use facility.There was not a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
It was reported that the short pointer broke off at the use facility.There was not a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
SMALL POINTER
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7601008
Report Number0001811755-2018-01065
Device Sequence Number232500
Product Code HAW
UDI-Device Identifier04546540245113
UDI-Public04546540245113
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K993239
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/23/2018
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
Operator of Device Health Professional
Device Catalogue Number6000-012-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2018
Initial Date Received by Manufacturer 05/22/2018
Supplement Date Received by Manufacturer07/23/2018
Initial Report FDA Received Date06/14/2018
Supplement Report FDA Received Date07/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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