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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, RIGHT POSTERIOR-FOSSA; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO POINTER, RIGHT POSTERIOR-FOSSA; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6001-022-000
Device Problems Imprecision (1307); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2020
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the device tip was bent after validation.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during a procedure at the user facility the device tip was bent after validation.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
POINTER, RIGHT POSTERIOR-FOSSA
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10600999
MDR Text Key209004540
Report Number0001811755-2020-02522
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540245809
UDI-Public04546540245809
Combination Product (y/n)N
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6001-022-000
Device Catalogue Number6001-022-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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