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

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NEURAY® PACKING NEUROSURGICAL PADDIE

  • 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 XOMED INC. NEURAY® PACKING NEUROSURGICAL PADDIE Back to Search Results
Model Number 8004000
Device Problems Material Separation (1562); Device Or Device Fragments Location Unknown (2590)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/26/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product evaluation: analysis results are not available; no device returned for evaluation.
 
Event Description
It was reported that during a spinal procedure, "when removing a neuray patty the string detached and came out of the patient and the patty stayed. They x-rayed the patient but the patty was not detected. They used another neuray patty in the patient's wound and performed another x-ray and the new patty was also not detected by the x-ray. " the second neuray patty was discarded, the first remains in the patient, or, was possibly discarded with removed tissue. There was no patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEURAY® PACKING
Type of DeviceNEUROSURGICAL PADDIE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
Manufacturer Contact
michelle alford
6743 southpoint drive north
jacksonville, FL 32216
9043328197
MDR Report Key5738500
MDR Text Key102473094
Report Number1045254-2016-00197
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K923027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8004000
Device Catalogue Number8004000
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 Received05/27/2016
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

-
-