5321G WILSON FRAME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-03-17 for 5321G WILSON FRAME manufactured by Mizuho Orthopedic Systems, Inc..

Event Text Entries

[16487371] Failure to be evaluated will and will advise upon receipt.
Patient Sequence No: 1, Text Type: N, H10

[16582636] After use, it was noted that the frame separated where the carbon fiber is placed by the customer into the formed plastic section. The customer has used this device since 2006.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2921578-2011-00008
• MDR Report Key: 2049647
• Report Source: 08
• Date Received: 2011-03-17
• Date of Report: 2011-03-15
• Date of Event: 2011-03-05
• Date Facility Aware: 2011-03-05
• Date Mfgr Received: 2011-03-09
• Date Added to Maude: 2011-05-06
• 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: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: KIRKE JAYNE
• Manufacturer Street: 30031 AHERN AVE.
• Manufacturer City: UNION CITY CA 945871234
• Manufacturer Country: US
• Manufacturer Postal: 945871234
• Manufacturer Phone: 5104768128
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 5321G WILSON FRAME
• Generic Name: OPERATING ROOM TABLE ACCESSORY
• Product Code: JEB
• Date Received: 2011-03-17
• Model Number: 5321G
• Catalog Number: 5321G
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Manufacturer Address: 30031 AHERN AVE. UNION CITY CA 94587123 US 94587 1234

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-03-17