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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-999-002
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  malfunction  
Event Description
It was reported that during set-up for a procedure conducted at the user facility the device had a spring fall out.A spring falling out during a surgical procedure could cause an infection.The device was not used after discovering the spring fell out.No known patient involvement or procedural delays were reported due to the incident.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during set-up for a procedure conducted at the user facility the device had a spring fall out.A spring falling out during a surgical procedure could cause an infection.The device was not used after discovering the spring fell out.No known patient involvement or procedural delays were reported due to the incident.
 
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Brand Name
NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM
Type of Device
NEUROLOGICAL 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 Key7148405
MDR Text Key95850148
Report Number0001811755-2017-02498
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6000-999-002
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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