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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007-003-000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2014
Event Type  malfunction  
Event Description
It was reported that the coupling for orthopedia anchoring system become loose while the surgeon was reaming the acetabulum during the course of a total hip replacement procedure.It was reported that the tracker moved from its original position, which has the potential to cause accuracy issues if not noticed by the user during a procedure.Navigation was canceled, the procedure was completed successfully using traditional methods.No adverse consequences, no medical intervention, and no surgical delay were reported with this event.
 
Manufacturer Narrative
The device was not returned for analysis; it was not possible to determine the cause of the reported event without an evaluation of the device.The device was not available for evaluation.
 
Event Description
It was reported that the coupling for orthopedia anchoring system become loose while the surgeon was reaming the acetabulum during the course of a total hip replacement procedure.It was reported that the tracker moved from its original position, which has the potential to cause accuracy issues if not noticed by the user during a procedure.Navigation was canceled, the procedure was completed successfully using traditional methods.No adverse consequences, no medical intervention, and no surgical delay were reported with this event.
 
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Brand Name
COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM
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 (MDR)
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4044352
MDR Text Key4803264
Report Number0001811755-2014-03073
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K022365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6007-003-000
Device Lot NumberD/01/2011
Is the Reporter a Health Professional? No
Date Manufacturer Received08/10/2015
Was Device Evaluated by Manufacturer? No
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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