CRANIAL ACCESS SINGLE STERILE HAND DRILL * 030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-18 for CRANIAL ACCESS SINGLE STERILE HAND DRILL * 030 manufactured by Clinical Neuro Systems.

Event Text Entries

[330026] The hand drill broke while in use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028223-2003-00015
MDR Report Key485947
Date Received2003-09-18
Date Mfgr Received2003-08-22
Date Added to Maude2003-10-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJENNA KARABAS
Manufacturer Street311C ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362236
Manufacturer G1CLINICAL NEURO SYSTEMS
Manufacturer Street309 COMMERCE DRIVE
Manufacturer CityEXTON PA 19341
Manufacturer CountryUS
Manufacturer Postal Code19341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRANIAL ACCESS SINGLE STERILE HAND DRILL
Generic NameCRANIAL ACCESS
Product CodeHBG
Date Received2003-09-18
Returned To Mfg2003-08-29
Model Number*
Catalog Number030
Lot NumberT03011
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key474832
ManufacturerCLINICAL NEURO SYSTEMS
Manufacturer Address309 COMMERCE DR. EXTON PA 19341 US
Baseline Brand NameCRINIAL ACCESS SINGLE STERILE HAND DRILL
Baseline Generic NameCRINIAL ACCESS
Baseline Model No*
Baseline Catalog No030
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2003-09-18

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