MAUDE Adverse Event Report: MIZUHO OSI JACKSON TABLE; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Device Problems Break (1069); Malposition of Device (2616); Device Fell (4014)

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

Event Date 12/27/2018

Event Type  No Answer Provided  

Event Description

About 4 hours into the case, while the last t1 screw was being cannulated with the gear shift, the bed suddenly broke and fell.The head was held quickly.The staff readjusted the bed, reapplied a pin to hold it all stable.At the end of the case, patient had good signals and no change from baseline.Appears that the table has two pins that can be removed.One pin was not in the correct place, which was identified per the staff members.

• Brand Name: JACKSON TABLE
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587
• MDR Report Key: 8248178
• MDR Text Key: 133074569
• Report Number: 8248178
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA