JACKSON SPINAL TABLE 5943 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-18 for JACKSON SPINAL TABLE 5943 * manufactured by Orthopedic Systems, Inc.

Event Text Entries

[465065] The pt was transferred on to the jackson spinal table. The pt was not in correct position, so the physician pressed the button to turn the pt and she fell off table. The locking mechanism is not fail safe and if the turn handle is left at a certain point and not cranked all the way around to the locking position, the table will move and the pt will fall off. When the handle is turned, the user does experience some resistance at this initial point and it appears as if the lock has latched.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038736
• MDR Report Key: 707897
• Date Received: 2006-04-18
• Date of Report: 2006-04-13
• Date of Event: 2006-04-11
• Date Added to Maude: 2006-05-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: JACKSON SPINAL TABLE
• Generic Name: JACKSON TABLE
• Product Code: JFB
• Date Received: 2006-04-18
• Model Number: 5943
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 696948
• Manufacturer: ORTHOPEDIC SYSTEMS, INC
• Manufacturer Address: * UNION CITY CA * US

Device Sequence Number: 2

• Brand Name: JACKSON SPINAL TABLE
• Generic Name: JACKSON TABLE
• Product Code: JFB
• Date Received: 2006-04-18
• Model Number: 5803
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 696975
• Manufacturer: ORTHOPEDIC SYSTEMS, INC
• Manufacturer Address: * UNION CITY CA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-04-18