MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MIZUHOSI; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number ORTSYS 5890

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/21/2018

Event Type  Injury  

Event Description

Following hip fx surgery, ortho table failure occurred.Right buttock support gave and patient tipped to the right side.Patient was caught and did not hit the floor, but the event resulted in an additional distal torsion fracture that resulted in surgical intervention.

• Brand Name: MIZUHOSI
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC. ; union city CA
• MDR Report Key: 7502476
• MDR Text Key: 108004005
• Report Number: MW5077122
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORTSYS 5890
• Device Catalogue Number: 5890
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 68