MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-08-19 for TSRH 3D 6.5 X 50 MM SCREW, TI 8372650 manufactured by Medtronic Sofamor Danekmanufacturing.
| Report Number | 1030489-2004-00091 |
| MDR Report Key | 915879 |
| Report Source | 05 |
| Date Received | 2004-08-19 |
| Date of Report | 2004-07-20 |
| Date of Event | 2004-07-20 |
| Date Added to Maude | 2007-09-21 |
| 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 TREHAME, PH.D. |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS IN 46852 |
| Manufacturer Country | US |
| Manufacturer Postal | 46852 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRO IC SOFAMOR DANEK MANUFACTURING |
| 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 | TSRH 3D 6.5 X 50 MM SCREW, TI |
| Generic Name | BONE SCREW |
| Product Code | KWG |
| Date Received | 2004-08-19 |
| Model Number | NA |
| Catalog Number | 8372650 |
| 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 | 889024 |
| Manufacturer | MEDTRONIC SOFAMOR DANEKMANUFACTURING |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-08-19 |