MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-01-19 for CD HORIZON SPINAL SYSTEM 7575300 manufactured by Warsaw Orthopedic Inc..
[593457]
It was reported that the rod inserter could not be taken out from the setscrew during the surgery. The surgeon had to make an incision to take the inserter out and used another inserter to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
[7821532]
Device was not returned for evaluation. Unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2007-00017 |
| MDR Report Key | 812881 |
| Report Source | 07 |
| Date Received | 2007-01-19 |
| Date of Report | 2006-12-21 |
| Date of Event | 2006-12-21 |
| Date Mfgr Received | 2006-12-21 |
| Date Added to Maude | 2007-02-08 |
| 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 | CHRISTINE SCIFERT, MS |
| 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 | ROD INSERTER |
| Product Code | HBS |
| Date Received | 2007-01-19 |
| Model Number | NA |
| Catalog Number | 7575300 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 800365 |
| Manufacturer | WARSAW ORTHOPEDIC INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 4682 US |
| Baseline Brand Name | CD HORIZON SPINAL SYSTEM |
| Baseline Generic Name | ROD INSERTER |
| Baseline Model No | NA |
| Baseline Catalog No | 7575300 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-19 |