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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNIVERSAL TRACKER EM; STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO UNIVERSAL TRACKER EM; STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 01 046 02
Device Problems Incorrect Measurement (1383); Insufficient Information (3190)
Patient Problems Cerebrospinal Fluid Leakage (1772); Tissue Damage (2104)
Event Date 08/30/2019
Event Type  Injury  
Event Description
It was reported that during surgery, the surgeon unknowingly advanced the device past the skull base into the brain causing a cerebral spinal fluid (csf) leak.The surgeon had to create a soft tissue flap to repair the dura; the patient remained under observation for an additional day.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during surgery, the surgeon unknowingly advanced the device past the skull base into the brain causing a cerebral spinal fluid (csf) leak.The surgeon had to create a soft tissue flap to repair the dura; the patient remained under observation for an additional day.
 
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Brand Name
UNIVERSAL TRACKER EM
Type of Device
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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key9104671
MDR Text Key159621109
Report Number0001811755-2019-03053
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number01 046 02
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2019
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
02 040 04 HYBRID NAVIGATION UNIT SERIAL: (B)(4); 8000-020-001 BASIC NOVA ENT VERSION 3.4.1
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