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..
[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
Report Number | 1030489-2005-00132 |
MDR Report Key | 606352 |
Report Source | 07 |
Date Received | 2005-05-18 |
Date of Report | 2005-04-21 |
Date of Event | 2005-04-21 |
Date Mfgr Received | 2005-04-21 |
Date Added to Maude | 2005-05-26 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | RICHARD TREHARNE, PH.D. |
Manufacturer Street | 1800 PYRAMID PLACE |
Manufacturer City | MEMPHIS TN 38132 |
Manufacturer Country | US |
Manufacturer Postal | 38132 |
Manufacturer Phone | 9013963133 |
Manufacturer G1 | WARSAW ORTHOPEDIC INC. |
Manufacturer Street | 2500 SILVEUS CROSSING |
Manufacturer City | WARSAW IN 46852 |
Manufacturer Country | US |
Manufacturer Postal Code | 46852 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CD HORIZON SPINAL SYSTEM |
Generic Name | BONE SCREW |
Product Code | JBS |
Date Received | 2005-05-18 |
Model Number | NA |
Catalog Number | 76446540 |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | Y |
Date Removed | U |
Device Sequence No | 1 |
Device Event Key | 596134 |
Manufacturer | WARSAW ORTHOPEDIC INC. |
Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
Baseline Brand Name | CD HORIZON SPINAL SYSTEM |
Baseline Generic Name | BONE SCREW |
Baseline Model No | NA |
Baseline Catalog No | 76446540 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2005-05-18 |