• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paralysis (1997); Numbness (2415)
Event Date 09/06/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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. Medtronic 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.
 
Event Description
It was reported that patient underwent balloon kyphoplasty surgery on (b)(6) 2016 for primary osteoporosis-compression fracture. On (b)(6) 2016, post-op, paralysis was observed. The patient exhibited numbness after undergoing th11 balloon kyphoplasty. Posterior fusion was performed between th8 to l2. Postoperative course was unknown. There was a delay of more than 60 minutes in the procedure. The patient issue was resolved.
 
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 Key5996032
MDR Text Key100488900
Report Number1030489-2016-02750
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 09/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2016
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2016
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 Initial

Patient Treatment Data
Date Received: 10/04/2016 Patient Sequence Number: 1
-
-