MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-01-14 for TSRH SPINAL SYSTEM UNK manufactured by Sofamor Danek Manufacturing.
[142816]
Implant date: 10/26/1998. X-rays revealed tsrh bolt slipped off end of rod on the right side. Revision surgery performed on 12/11/1998 to remove and replace the construct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-1999-00005 |
| MDR Report Key | 206608 |
| Report Source | 07 |
| Date Received | 1999-01-14 |
| Date of Report | 1998-12-15 |
| Date of Event | 1998-12-11 |
| Date Mfgr Received | 1998-12-15 |
| Date Added to Maude | 1999-01-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TSRH SPINAL SYSTEM |
| Generic Name | SPINAL FIXATION SYSTEM |
| Product Code | LYP |
| Date Received | 1999-01-14 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 200545 |
| Manufacturer | SOFAMOR DANEK MANUFACTURING |
| Manufacturer Address | 100 PUBLISHERS DRIVE WINONA LAKE IN 46590 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-01-14 |