CD HORIZON SOLERA SPINAL SYSTEM 651003045

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 2020-03-28 for CD HORIZON SOLERA SPINAL SYSTEM 651003045 manufactured by Warsaw Orthopedics.

Event Text Entries

[186574215] 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


[186574216] Pre op diagnosis: loose set screws procedure performed: revision surgery to replace loose set screws post-op, patient suffered from pain. There was no malfunction associated with the rod, it is just a part of construct.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00387
MDR Report Key9892548
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-28
Date of Report2020-03-28
Date Mfgr Received2020-03-02
Device Manufacturer Date2018-10-24
Date Added to Maude2020-03-28
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 NameCD HORIZON SOLERA SPINAL SYSTEM
Generic NameORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Product CodeNKB
Date Received2020-03-28
Model NumberNA
Catalog Number651003045
Lot Number0680890W
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerWARSAW ORTHOPEDICS
Manufacturer Address2500 SILVEUS CROSSING WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-28

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