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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER ZYPHR DISPOSABLE CRANIAL PERFORATOR; LARGE 14/11MM

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STRYKER INSTRUMENTS STRYKER ZYPHR DISPOSABLE CRANIAL PERFORATOR; LARGE 14/11MM Back to Search Results
Model Number 5100-060-001
Device Problems Failure to Sense (1559); Device Operates Differently Than Expected (2913)
Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104); Hydrocephalus (3272)
Event Date 01/02/2014
Event Type  Injury  
Event Description
Patient had a shunt placement procedure for hydrocephalus on (b)(6) 2014.During the procedure, the surgeon reported that the burr penetrated the dura and went into the brain causing potential injury/hemorrhage.Ct performed on (b)(6) 2014 and showed a minimal peritract low attenuation hemorrhage seen within the right frontal lobe.
 
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Brand Name
STRYKER ZYPHR DISPOSABLE CRANIAL PERFORATOR
Type of Device
LARGE 14/11MM
Manufacturer (Section D)
STRYKER INSTRUMENTS
kalamazoo MI 49001
MDR Report Key3632426
MDR Text Key16224701
Report Number3632426
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 01/10/2014
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 Model Number5100-060-001
Device Catalogue Number0043199
Device Lot Number3140901132560173
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/10/2014
Distributor Facility Aware Date01/02/2014
Event Location Hospital
Date Report to Manufacturer01/02/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/10/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight84
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