MAYFIELD MODIFIED SKULL CLAMP A1059

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-06 for MAYFIELD MODIFIED SKULL CLAMP A1059 manufactured by Integra Lifesciences Corporation Oh/usa.

MAUDE Entry Details

Report Number3004608878-2019-01072
MDR Report Key9286143
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-06
Date of Report2019-10-16
Date of Event2019-09-27
Date Mfgr Received2019-10-16
Date Added to Maude2019-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. VIVIAN NELSON
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362319
Manufacturer G1INTEGRA LIFESCIENCES CORPORATION OH/USA
Manufacturer Street4900 CHARLEMAR DRIVE
Manufacturer CityCINCINNATI OH 45227
Manufacturer CountryUS
Manufacturer Postal Code45227
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAYFIELD MODIFIED SKULL CLAMP
Generic NameSKULL CLAMPS AND HEADREST SYSTEMS
Product CodeHBL
Date Received2019-11-06
Catalog NumberA1059
Lot Number157
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION OH/USA
Manufacturer Address4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-06

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