CD HORIZON SPINAL SYSTEM 76446540

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 2005-05-18 for CD HORIZON SPINAL SYSTEM 76446540 manufactured by Warsaw Orthopedic Inc..

Event Text Entries

[16301039] It was reported that approx 1 year post op, x-rays showed that both s1 screws were broken. The device has not been explanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2005-00132
MDR Report Key606352
Report Source07
Date Received2005-05-18
Date of Report2005-04-21
Date of Event2005-04-21
Date Mfgr Received2005-04-21
Date Added to Maude2005-05-26
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 Location0
Manufacturer ContactRICHARD TREHARNE, PH.D.
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 Received2005-05-18
Model NumberNA
Catalog Number76446540
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedU
Device Sequence No1
Device Event Key596134
ManufacturerWARSAW ORTHOPEDIC INC.
Manufacturer Address2500 SILVEUS CROSSING WARSAW IN 46852 US
Baseline Brand NameCD HORIZON SPINAL SYSTEM
Baseline Generic NameBONE SCREW
Baseline Model NoNA
Baseline Catalog No76446540
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2005-05-18

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