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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SHORT SPINE CLAMP FOR SPINE NAVIGATION PACKAGE; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SHORT SPINE CLAMP FOR SPINE NAVIGATION PACKAGE; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6002-014-000
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the device was broken.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Event Description
It was reported that during a procedure at the user facility the device was broken.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Update: d9, h3, h6.Device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
SHORT SPINE CLAMP FOR SPINE NAVIGATION PACKAGE
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12281469
MDR Text Key265187846
Report Number3015967359-2021-01734
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540350190
UDI-Public04546540350190
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6002-014-000
Device Catalogue Number6002-014-000
Device Lot NumberA/01/2013
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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