CD HORIZON SPINAL SYSTEM 5531113

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 SPINAL SYSTEM 5531113 manufactured by Warsaw Orthopedics.

Event Text Entries

[186539777] Other: transverse process fracture. This part is not approved for use in the united states; however a like device catalog # 5541113, 510k # k132471 and udi # (b)(4) was cleared in the united states. 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


[186539778] It was reported that the patient presented with kyphosis; and underwent thoraco-lumbar vertebral posterior fixation. In this surgery, the pedicles were thin, and the plan was to place transverse process hooks (wide blade hooks) at t4 and t5. The medium sized hooks were chosen by trial. When the actual hooks were placed at t5, the transverse process on both sides fractured; and the hooks could no longer be placed. As hooks were already placed at t4, hook placement at t5 was skipped. This had no impact on the operation, which was completed successfully. No other patient complications were reported other than transverse processes fracture as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00391
MDR Report Key9893278
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-28
Date of Report2020-03-28
Date of Event2020-03-06
Date Mfgr Received2020-03-09
Device Manufacturer Date2016-05-07
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 SPINAL SYSTEM
Product CodeNKB
Date Received2020-03-28
Model NumberNA
Catalog Number5531113
Lot Number0475944W
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.