• 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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Awl has not been received for evaluation. Answers to questions about the reported incident have not been received either.
 
Event Description
The tip of the awl was broken during a case. No additional information provided.
 
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
charlene brumbaugh
452 alexandersville road
miamisburg, OH 45342
9378478400
MDR Report Key6926112
MDR Text Key89940475
Report Number3005031160-2017-00160
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 10/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberT066-0205
Device Lot NumberEM12M005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/07/2017 Patient Sequence Number: 1
-
-