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

Model Number 5943

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 03/03/2015

Event Type  Injury  

Event Description

(b)(6) director of perioperative surgery call in reporting an issue with their 5803 abd 5943 spinal frame.While performing spinal procedure, (b)(6) stated that "one of the t-pins on the head end worked its way out and the tabletop and pt fell." the pt suffered an injury to their head requiring 3 staples to close the wound.(b)(6) also stated that they found after the fall 2 hip pads were found broken (service ticket 80000004862).A request was also placed to our sales dept to perform an in-service on the use of the table.

Manufacturer Narrative

User facility confirmed this is the same event that was later reported in voluntary event report mw5041555.Investigation found no defects in the equipment.It was determined that additional training was needed; in-service training was performed 03/06/2015.

• Brand Name: SPINAL SURGICAL TABLE TOP
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave.; 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, CA 94587-1234 ; 5104291500
• MDR Report Key: 4658042
• MDR Text Key: 20785795
• Report Number: 2921578-2015-00009
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2011
• 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): Required Intervention
• Patient Weight: 165