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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 Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2017
Event Type  malfunction  
Manufacturer Narrative
Awl has not been received for evaluation, however part number and lot number information was received.
 
Event Description
The tip of the guided angle awl broke during surgery, it was already a little bent. There was no injury caused to the patient. The straight awl was then used to complete the surgery.
 
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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
charlene brumbaugh
452 alexandersville road
miamisburg, OH 45342
9378478400
MDR Report Key7001813
MDR Text Key91250757
Report Number3005031160-2017-00161
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodePO
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 11/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberT066-0205
Device Lot NumberEM14F003
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 Received10/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2014
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: 11/03/2017 Patient Sequence Number: 1
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