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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAV PIN 3MM X 100MM CASE OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO NAV PIN 3MM X 100MM CASE OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007003100
Device Problem Fracture (1260)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/14/2020
Event Type  Injury  
Manufacturer Narrative
Device discarded.
 
Event Description
It was reported that during a procedure at the user facility a patient experienced a fracture of the femur at the diaphysis.Attempts are being made to obtain additional information about the event; no further information is currently available.
 
Manufacturer Narrative
Additional information added for d10, h3 device evaluation: follow-up report submitted to document the device was discarded by the customer, no evaluation is possible.H3 other text : device and x-rays not available.
 
Event Description
It was reported that during a procedure at the user facility a patient experienced a fracture of the femur at the diaphysis.The user facility reported the patient recovered from the fracture.Multiple attempts were made to obtain additional information.The user facility was not able to provide any further information regarding the reported event.
 
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Brand Name
NAV PIN 3MM X 100MM CASE OF 10
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9800125
MDR Text Key182393100
Report Number0001811755-2020-00629
Device Sequence Number1
Product Code HAW
UDI-Device Identifier57613154107396
UDI-Public57613154107396
Combination Product (y/n)N
PMA/PMN Number
K022365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6007003100
Was Device Available for Evaluation? No
Date Manufacturer Received07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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