• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. A JACKSON SPINAL TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MIZUHO ORTHOPEDIC SYSTEMS, INC. A JACKSON SPINAL TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Injury (2348)
Event Date 12/17/2007
Event Type  Injury  
Event Description
I had 15-s1 plif, and immediately had pelvic pain. I recently went to dr. (b)(6). He said i was injured from the operating room table during my surgery. I had my plif at (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameA JACKSON SPINAL TABLE
Type of DeviceTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
MDR Report Key7553243
MDR Text Key109661862
Report NumberMW5077515
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
-
-