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 UNK manufactured by Warsaw Orthopedic Inc..
[17909232]
It was reported that x-rays taken approx 5 1/2 months post op showed that the head of a screw disassociated from the shaft of the screw. The device has not been explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2005-00134 |
| MDR Report Key | 606345 |
| Report Source | 07 |
| Date Received | 2005-05-18 |
| Date of Report | 2005-04-21 |
| Date of Event | 2005-03-11 |
| 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 | UNK |
| 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 | 596127 |
| Manufacturer | WARSAW ORTHOPEDIC INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-18 |