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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 T066-0061
Device Problem Bent (1059)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/02/2017
Event Type  Injury  
Manufacturer Narrative

The awl was found to be bent at the distal tip, it is not known if this was due to the patient's hard bone or the surgeon's failure to use the guided instrumentation that must be used with this system.

 
Event Description

During a revision surgery to remove non x-spine cervical plate and replace it with irix-c implant on adjacent levels, there were complications with hard bone. The surgeon used several tools to try to start a pilot hole; the freehand awl was bent, the guided angled awl was broken, a 14mm drill was bent, a 14mm drill was broken, and one straight awl was bent. There were no patient injuries due to the broken and bent instruments. Surgeon was able to start a pilot hole with a self-drilling screw after several attempts.

 
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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 Key6645779
MDR Text Key77702839
Report Number3005031160-2017-00140
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 COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 06/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberT066-0061
Device LOT Number67629
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/18/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/15/2017 Patient Sequence Number: 1
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