5855 ORTHOPEDIC TABLE SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-09-06 for 5855 ORTHOPEDIC TABLE SYSTEM manufactured by Mizuho Osi.

Event Text Entries

[16104521] The carbon fiber spar supporting the table top is separating from its mount.
Patient Sequence No: 1, Text Type: D, B5

[16338488] Initial notification of event, advisement after completion of complaint ((b)(6) 2011).
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2921578-2011-00025
• MDR Report Key: 2244794
• Report Source: 06,07
• Date Received: 2011-09-06
• Date of Report: 2011-09-05
• Date Mfgr Received: 2011-09-02
• Device Manufacturer Date: 2002-02-01
• Date Added to Maude: 2012-06-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: KIRKE JAYNE
• Manufacturer Street: 30031 AHERN AVENUE
• Manufacturer City: UNION CITY CA 945871234
• Manufacturer Country: US
• Manufacturer Postal: 945871234
• Manufacturer G1: MIZUHO OSI
• Manufacturer Street: 30031 AHERN AVENUE
• Manufacturer City: UNION CITY CA 94587123
• Manufacturer Country: US
• Manufacturer Postal Code: 94587 1234
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 5855 ORTHOPEDIC TABLE SYSTEM
• Generic Name: OPERATING ROOM TABLE
• Product Code: JEB
• Date Received: 2011-09-06
• Model Number: 5855
• Catalog Number: 5855
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIZUHO OSI
• Manufacturer Address: 30031 AHERN AVENUE UNION CITY CA 94587123 US 94587 1234

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-09-06