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U.S. Department of Health and Human Services

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

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X-SPINE SYSTEMS, INC. IRIX-C GUIDED ANGLE AWL Back to Search Results
Model Number T066-0205
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/12/2016
Event Type  malfunction  
Manufacturer Narrative
Root cause cannot be reliably determined based on the information available for evaluation.
 
Event Description
During an acdf from c5-c7, as surgeon was withdrawing the angled awl from freehand guide, the awl snapped and the tip was broken off. Procedure was completed using the straight awl. There was no additional surgical intervention or patient injury. The tip fragment was returned with the awl to manufacturer x-spine, systems lnc.
 
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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 Key5434685
MDR Text Key38775178
Report Number3005031160-2015-00050
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 company representative,distri
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 01/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberT066-0205
Device Lot NumberEM13M002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2016
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: 02/12/2016 Patient Sequence Number: 1
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