CD HORIZON SPINAL SYSTEM UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-04-20 for CD HORIZON SPINAL SYSTEM UNK manufactured by Warsaw Orthopedic Inc.

Event Text Entries

[456817] It was reported by a non-medical professional that a revision surgery was performed due to a broken screw.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2006-00107
MDR Report Key703238
Report Source07
Date Received2006-04-20
Date of Report2006-04-07
Date Mfgr Received2006-04-07
Date Added to Maude2006-04-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactRICHARD TREHARNE, PHD
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1WARSAW ORTHOPEDIC INC
Manufacturer Street2500 SILVEUS CROSSING
Manufacturer CityWARSAW IN 46852
Manufacturer CountryUS
Manufacturer Postal Code46852
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCD HORIZON SPINAL SYSTEM
Generic NameBONE SCREW
Product CodeJBS
Date Received2006-04-20
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key692360
ManufacturerWARSAW ORTHOPEDIC INC
Manufacturer Address2500 SILVEUS CROSSING WARSAW IN 46852 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2006-04-20

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