MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. SPINAL SURGERY TOP

Model Number 5943

Device Problems Detachment Of Device Component (1104); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

It is true, as stated by the initial reporter, that if a healthcare professional placed a patient on a damaged table, the patient could fall and be seriously injured.The instructions provided with this table do warn the users to inspect the equipment before each use, and not to use damaged equipment.A semi-annual preventive maintenance and inspection by a qualified technician is also required.

Event Description

From medwatch report: epoxy glue detaching from aluminum plug attachment point.Could cause pt injury or death.From 2011-2016 hospital would send table tops back to mfr.

• Brand Name: SPINAL SURGERY TOP
• Type of Device: SPINAL SURGERY TOP
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city 94587-1234 ; 5104291500
• MDR Report Key: 5813033
• MDR Text Key: 50179969
• Report Number: 2921578-2016-00014
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other