OSI MODULAR TABLE 5803

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-04 for OSI MODULAR TABLE 5803 manufactured by Orthopedic Systems, Inc..

Event Text Entries

[16106600] Rectangular object discovered upon x-ray with c-arm during surgery with patient positioned prone on jackson table. Object discovered to be inside hip pad attachment to the table. No patient injury occurred and surgery was completed. Company representative notified via phone in 2008. Osi rep robyn mcdaniel said she would get back to us.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5008861
MDR Report Key1220705
Date Received2008-11-04
Date of Report2008-10-24
Date of Event2008-10-09
Date Added to Maude2008-11-13
Event Key0
Report Source CodeVoluntary 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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameOSI MODULAR TABLE
Generic NameJACKSON TABLE
Product CodeJFB
Date Received2008-11-04
Model Number5803
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1273983
ManufacturerORTHOPEDIC SYSTEMS, INC.
Manufacturer Address30031 AHERN UNION CITY CA 94587 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-11-04

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