ATLAS CABLE SYSTEM 826-213

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-04 for ATLAS CABLE SYSTEM 826-213 manufactured by Warsaw Orthopedics.

Event Text Entries

[119026991] Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[119026992] Pre-op diagnosis: axial dislocation with incomplete spinal nerve injury, posterior arch nonunion, lumbar 5/ sacral 1 disc herniation procedure: open reduction of axial dislocation via posterior approach, decompression of spinal canal and cantilever beam internal fixation it was reported that intra-op, a single cable with integral crimp broke during the procedure. The product came in contact with the patient. There are no known complications to the patient in the reported event.
Patient Sequence No: 1, Text Type: D, B5


[125501742] Product analysis: the cable was returned with a fracture at the weld junction. A microscopic review of the fracture face reveals a ductile failure with a concaved surface consistent with necking near the failure point. This is consistent with a tensile overload on the axis of the cable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2018-01200
MDR Report Key7841130
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-09-04
Date of Report2018-10-23
Date of Event2018-08-10
Date Mfgr Received2018-10-22
Device Manufacturer Date2018-03-19
Date Added to Maude2018-09-04
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 ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1WARSAW ORTHOPEDICS
Manufacturer Street2500 SILVEUS CROSSING
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATLAS CABLE SYSTEM
Generic NameCABLE
Product CodeISN
Date Received2018-09-04
Returned To Mfg2018-10-10
Model NumberNA
Catalog Number826-213
Lot Number0640587W
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerWARSAW ORTHOPEDICS
Manufacturer Address2500 SILVEUS CROSSING WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.