FDA Adverse Event Injury Summary report: N

MTS ORTHOPEDIC TRAUMA TOP

MDR report key: 17792041 · Received September 21, 2023

Report

Report Number
2921578-2023-00016
Event Type
Injury
Date Received
September 21, 2023
Date of Event
March 30, 2011
Report Date
October 17, 2023
Manufacturer
MIZUHO OSI
Product Code
JEA
UDI-DI
00842430105999
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
DC, US
Reporter Occupation
501

Narratives

Additional Manufacturer Narrative · 0

OSHA INSPECTION NR. (B)(4), REPORT ID (B)(6), DATE OPENED 04/15/2011 REPORT DESCRIBES UNSECURED EQUIPMENT IN STORAGE ROOM FALLING ON EMPLOYEE.

Description of Event or Problem · 0

EMPLOYEE ENGAGED IN OPERATING AND MAINTENANCE ACTIVITIES AT A MEDICAL CENTER AND WENT INTO THE OPERATING ROOM EQUIPMENT STORAGE ROOM TO ORGANIZE THE EQUIPMENT FOR THE PLACEMENT OF ANOTHER TABLE. HE ATTEMPTED TO WALK BETWEEN TWO MIZUHO OSI JACKSON ORTHOPEDIC FRACTURE TABLES (MODEL NUMBER (B)(6)) WHICH WERE USED FOR FRACTURED HIP SURGERY. WHILE REPOSITIONING EQUIPMENT, AN UNHOOKED TRACTION ARC BECAME LOOSE THAT CAUSED A POSITIONING LEG HOLDER PIECE TO FALL. THIS PIECE OF EQUIPMENT, WHICH WEIGHTED 20 LBS, FELL OFF A TABLETOP, HITTING EMPLOYEE'S RIGHT FOOT AND INJURING HIS TOE. THE INJURY RESULTED IN A SERIOUS INFECTION. HE WAS TREATED AT A MEDICAL CENTER, WHERE HE UNDERWENT TREATMENT FOR THE TOE INFECTION AND WAS HOSPITALIZED.

Description of Event or Problem · 0

EMPLOYEE ENGAGED IN OPERATING AND MAINTENANCE ACTIVITIES AT A MEDICAL CENTER AND WENT INTO THE OPERATING ROOM EQUIPMENT STORAGE ROOM TO ORGANIZE THE EQUIPMENT FOR THE PLACEMENT OF ANOTHER TABLE. HE ATTEMPTED TO WALK BETWEEN TWO MIZUHO OSI JACKSON ORTHOPEDIC FRACTURE TABLES (MODEL NUMBER 5890) WHICH WERE USED FOR FRACTURED HIP SURGERY. WHILE REPOSITIONING EQUIPMENT, AN UNHOOKED TRACTION ARC BECAME LOOSE THAT CAUSED A POSITIONING LEG HOLDER PIECE TO FALL. THIS PIECE OF EQUIPMENT, WHICH WEIGHTED 20 LBS, FELL OFF A TABLETOP, HITTING EMPLOYEE'S RIGHT FOOT AND INJURING HIS TOE. THE INJURY RESULTED IN A SERIOUS INFECTION. HE WAS TREATED AT A MEDICAL CENTER, WHERE HE UNDERWENT TREATMENT FOR THE TOE INFECTION AND WAS HOSPITALIZED. THE INJURY RESULTED IN SERIOUS INFECTION AND THE EMPLOYEE WAS HOSPITALIZED AND UNDERWENT TREATMENT FOR TOE INFECTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1938777 MTS ORTHOPEDIC TRAUMA TOP OPERATING TABLE JEA MIZUHO OSI 5855 00842430105999

Patients

Seq Age Sex Outcome Treatment
1 Male Hospitalization