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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6002-350-000
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that the device's tip had broken off during the service process. A tip breaking off during a procedure could lead to infection. No known patient involvement or procedural delays were reported with this event.
 
Event Description
It was reported that the device's tip had broken off during the service process. A tip breaking off during a procedure could lead to infection. No known patient involvement or procedural delays were reported with this event.
 
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Brand NameTHORACIC PEDICLE FEELER
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7126687
MDR Text Key192076691
Report Number0001811755-2017-02467
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K012380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6002-350-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1216-2018

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