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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC. AWL (STAINLESS STEEL) HWJ

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ALPHATEC SPINE, INC. AWL (STAINLESS STEEL) HWJ Back to Search Results
Model Number 73711
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/04/2018
Event Type  Injury  
Manufacturer Narrative
No evaluation possible at this time. The instrument has not been returned for evaluation. The illico awl is a cannulated instrument ground at 15° to form a sharp trocar tip intended to penetrate cortical bone during pedicle preparation. The section retained by the patient is manufactured from custom (b)(4) stainless steel which is processed and certified to astm (b)(4) specifications.
 
Event Description
The distal tip of an illico awl broke off during the mis case. The detached section remains captured within the patients l5 pedicle.
 
Manufacturer Narrative
An evaluation of the returned device confirmed the distal tip, approximately. 591 in length has been completely separated/detached from the instrument. Under magnification, the fracture patterns reveal lateral forces where applied to the instrument which caused the ø. 20" tip to encounter excessive fatigue/stress.
 
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Brand NameAWL (STAINLESS STEEL)
Type of DeviceHWJ
Manufacturer (Section D)
ALPHATEC SPINE, INC.
5818 el camino real
carlsbad CA 92008
Manufacturer Contact
richard younger
5818 el camino real
carlsbad, CA 92008
7604946842
MDR Report Key7482962
MDR Text Key107226470
Report Number2027467-2018-00023
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number73711
Device Catalogue Number73711
Device Lot Number5148702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2008
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: 05/03/2018 Patient Sequence Number: 1
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