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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER INSTRUMENTS; ZYPHR DISPOSABLE CRANIAL PERFORATOR

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STRYKER INSTRUMENTS STRYKER INSTRUMENTS; ZYPHR DISPOSABLE CRANIAL PERFORATOR Back to Search Results
Model Number REF 5100-060-001
Device Problem Insufficient Information (3190)
Patient Problem Tissue Damage (2104)
Event Date 04/26/2016
Event Type  Injury  
Event Description
A (b)(6) male in the operating room for the removal of a temporal mass, during drilling of the burr holes, the drill penetrated the dura of the brain.There was no harm to the patient and the rep for the company was called.The device was given to the rep at that time.
 
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Brand Name
STRYKER INSTRUMENTS
Type of Device
ZYPHR DISPOSABLE CRANIAL PERFORATOR
Manufacturer (Section D)
STRYKER INSTRUMENTS
6901 portage rd
portage MI 49002
MDR Report Key5723149
MDR Text Key47349418
Report Number5723149
Device Sequence Number1
Product Code HBF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2017
Device Model NumberREF 5100-060-001
Device Catalogue Number16077037
Device Lot NumberSS3170301160770373
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/29/2016
Distributor Facility Aware Date05/16/2016
Event Location Hospital
Date Report to Manufacturer05/29/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/13/2016
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age76 YR
Patient Weight87
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