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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TIBIAL/PELVIC TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO TIBIAL/PELVIC TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6003-005-000
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2014
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the healthcare facility, the tibial/pelvic tracker bent.It was reported that the procedure was completed successfully, without a delay.No medical intervention and no adverse consequences were reported.
 
Event Description
It was reported that during a surgical procedure at the healthcare facility, the tibial/pelvic tracker bent.It was reported that the procedure was completed successfully, without a delay.No medical intervention and no adverse consequences were reported.The additional information was reported by the healthcare facility, that the tracker was not used on a patient, as the bend was noticed by the surgeon at the beginning of the total knee procedure, and that the procedure was completed with navigation and with the use of a backup tracker.
 
Manufacturer Narrative
Additional information regarding the reported event was received from the healthcare facility.
 
Event Description
It was reported that during a surgical procedure at the healthcare facility, the tibial/pelvic tracker bent.It was reported that the procedure was completed successfully, without a delay.No medical intervention and no adverse consequences were reported.The additional information was reported by the healthcare facility, that the tracker was not used on a patient, as the bend was noticed by the surgeon at the beginning of the total knee procedure, and that the procedure was completed with navigation and with the use of a backup tracker.
 
Manufacturer Narrative
During the device evaluation, the tracker housing was found to be cracked and the coating was found to be damaged, but the reported event of a bent tracker could not be confirmed.
 
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Brand Name
TIBIAL/PELVIC TRACKER
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-79 111
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4522822
MDR Text Key5354265
Report Number0001811755-2015-00564
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6003-005-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received05/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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