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

MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-C GUIDED ANGLE AWL

  • 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
 

X-SPINE SYSTEMS, INC. IRIX-C GUIDED ANGLE AWL Back to Search Results
Model Number T066-0205
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The distal tip fragment of the awl was not returned for evaluation with the awl.
 
Event Description
Was returned due to broken with no communication from representative, found upon returning inspection broken at distal tip. Representative responded on (b)(6) 2017, the awl was broken during surgery, no problems from it. No patient injuries.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIRIX-C GUIDED ANGLE AWL
Type of DeviceAWL
Manufacturer (Section D)
X-SPINE SYSTEMS, INC.
452 alexandersville road
miamisburg OH 45342
Manufacturer Contact
kriss anderson
452 alexandersville road
miamisburg, OH 45342
9378478400
MDR Report Key6327186
MDR Text Key67321204
Report Number3005031160-2017-00114
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberT066-0205
Device Lot NumberEM13M002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/13/2017 Patient Sequence Number: 1
-
-