AWL (STAINLESS STEEL) 73711

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-03 for AWL (STAINLESS STEEL) 73711 manufactured by Alphatec Spine, Inc..

Event Text Entries

[107226470] 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.
Patient Sequence No: 1, Text Type: N, H10


[107226491] The distal tip of an illico awl broke off during the mis case. The detached section remains captured within the patients l5 pedicle.
Patient Sequence No: 1, Text Type: D, B5


[117897330] 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?. 20" tip to encounter excessive fatigue/stress.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2027467-2018-00023
MDR Report Key7482962
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-05-03
Date of Report2018-04-04
Date of Event2018-04-04
Date Mfgr Received2018-04-04
Device Manufacturer Date2008-07-11
Date Added to Maude2018-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RICHARD YOUNGER
Manufacturer Street5818 EL CAMINO REAL
Manufacturer CityCARLSBAD CA 92008
Manufacturer CountryUS
Manufacturer Postal92008
Manufacturer Phone7604946842
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAWL (STAINLESS STEEL)
Generic NameHWJ
Product CodeHWJ
Date Received2018-05-03
Returned To Mfg2018-05-07
Model Number73711
Catalog Number73711
Lot Number5148702
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALPHATEC SPINE, INC.
Manufacturer Address5818 EL CAMINO REAL CARLSBAD CA 92008 US 92008


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-03

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