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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-011-000
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
Event Type  malfunction  
Event Description
During the service evaluation process conducted at the manufacturer facility it was observed that the tip of the device was broken off.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
During the service evaluation process conducted at the manufacturer facility it was observed that the tip of the device was broken off.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
LARGE POINTER
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11878181
MDR Text Key252743535
Report Number3015967359-2021-00955
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540245106
UDI-Public04546540245106
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6000-011-000
Device Catalogue Number6000-011-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2021
Date Manufacturer Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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