CD HORIZON SPINAL SYSTEM 7578302

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 2020-03-29 for CD HORIZON SPINAL SYSTEM 7578302 manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[186552290] 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


[186552291] It was reported that the patient underwent thoraco-lumbar vertebral posterior fusion and fixation at t11-l3. Intra-op, after final fixation, the extender on the cranial side did not come off easily. When an attempt was made to remove the extender by slightly twisting it, it was checked that the part (which was like a claw) at the tip of the extender had broken off. This part was checked from the surgical incision, and the broken piece was removed. It was confirmed that no fragments of the product remained in the patient? S body. There was also some difficulty in attaching the extender to the screw. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5


[188490603] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188490604] Pre-operative diagnosis: burst fracture at l1 procedure involved: correction and posterior fixation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00397
MDR Report Key9895043
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-29
Date of Report2020-03-29
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2015-07-07
Date Added to Maude2020-03-29
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 G1MEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Street4340 SWINEA RD
Manufacturer CityMEMPHIS TN 38118
Manufacturer CountryUS
Manufacturer Postal Code38118
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCD HORIZON SPINAL SYSTEM
Generic NameORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Product CodeNKB
Date Received2020-03-29
Model NumberNA
Catalog Number7578302
Lot NumberEM15E022
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Address4340 SWINEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-29

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