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

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK ARTHROSCOPE

  • 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
 

MEDTRONIC SOFAMOR DANEK ARTHROSCOPE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bone Fracture(s) (1870); Neurological Deficit/Dysfunction (1982)
Event Date 09/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
 
Event Description
It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty for compression fracture due to osteoporosis. Intra-op, the surgeon damaged the inner portion of pedicle by mistake. He made a hole to the damaged part during the preparation for approach. When the surgeon filled the cement strongly, the cement came up to the posterior of vertebral body due to its pressure and cement leaked from the damaged part. The surgeon has admitted his technical error. It has also been reported that labeling was not followed throughout the procedure. Neurological symptom was observed at a later date as a result of this event. Revision surgery was performed for decompression.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5986216
MDR Text Key55872598
Report Number1030489-2016-02708
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/29/2016 Patient Sequence Number: 1
-
-