MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-10-15 for HINGED TIP CURETTE-8MM SWEEP * manufactured by Synthes (usa).
[18913736]
Surgeon complained that a patient expired during a three level vertebral body augmentation using synthes cavity creation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2003-00035 |
| MDR Report Key | 489917 |
| Report Source | 05 |
| Date Received | 2003-10-15 |
| Date of Report | 2003-09-19 |
| Date of Event | 2003-09-19 |
| Date Mfgr Received | 2003-09-19 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2003-10-21 |
| 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 | DEANNA HOFFMASTER |
| Manufacturer Street | 1690 RUSSELL ROAD |
| Manufacturer City | PAOLI PA 19301 |
| Manufacturer Country | US |
| Manufacturer Postal | 19301 |
| Manufacturer Phone | 6106479700 |
| Manufacturer G1 | MONUMENT MAIN FINISHED GOODS BRANCH/PLNT |
| Manufacturer Street | 1101 SYNTHES AVENUE P.O. BOX 366 |
| Manufacturer City | EL PASO |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HINGED TIP CURETTE-8MM SWEEP |
| Generic Name | CURETTES |
| Product Code | FZS |
| Date Received | 2003-10-15 |
| Returned To Mfg | 2003-09-30 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 478649 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1690 RUSSELL RD. PAOLI PA 19301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2003-10-15 |