MAYFIELD HEADREST A-1018 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-06 for MAYFIELD HEADREST A-1018 * manufactured by Integra.

Event Text Entries

[407831] During operation mayfield headrest shifted.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number651026
MDR Report Key651026
Date Received2005-12-06
Date of Report2005-12-02
Date of Event2005-12-01
Date Facility Aware2005-12-02
Report Date2005-12-02
Date Reported to FDA2005-12-02
Date Reported to Mfgr2005-12-02
Date Added to Maude2005-12-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameMAYFIELD HEADREST
Generic NameHAEADREST
Product CodeHBM
Date Received2005-12-06
Model NumberA-1018
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age4 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key655820
ManufacturerINTEGRA
Manufacturer Address4900 CHARLEMAR DR, BLDG. A CINCINNATI OH 45227 US

Device Sequence Number: 2

Brand NameMAYFIELD HEADREST
Generic NameHEADREST
Product CodeHBM
Date Received2005-12-06
Model NumberA-2001
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key643787
ManufacturerINTEGRA
Manufacturer Address4900 CHARLEMAR DR. BLDG., A CINCINNATI OH 45227 US

Patients

Patient NumberTreatmentOutcomeDate
10 2005-12-06
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