CD HORIZON SOLERA SPINAL SYSTEM 6540530

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 6540530 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.

Event Text Entries

[186572590] 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


[186572591] Pre op diagnosis: loose set screws procedure performed: revision surgery to replace loose set screws post-op, set screws back out. Initial post op x-ray looked intact but follow up x-ray set screw on right l5 screw noted to be not sitting in screw head. Revision surgery undertaken to replace set screw. The patient suffered pain as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00386
MDR Report Key9892534
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-28
Date of Report2020-03-28
Date Mfgr Received2020-03-02
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 G1MDT SOFAMOR DANEK PUERTO RICO MFG
Manufacturer StreetBARRIO MARIANNA RD 909, KM0.4
Manufacturer CityHUMACAO PR 00792
Manufacturer CountryUS
Manufacturer Postal Code00792
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 Number6540530
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMDT SOFAMOR DANEK PUERTO RICO MFG
Manufacturer AddressBARRIO MARIANNA RD 909, KM0.4 HUMACAO PR 00792 US 00792


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-28

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