MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2002-10-21 for ALPHA BONE SUBSTITUTE MATERIAL 76-5010 manufactured by Etex Corp..
[17116508]
Reported a deep infection 3 weeks post implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225112-2002-00001 |
| MDR Report Key | 423051 |
| Report Source | 01,05,06,08 |
| Date Received | 2002-10-21 |
| Date of Report | 2002-10-18 |
| Date of Event | 2002-08-13 |
| Date Mfgr Received | 2002-09-20 |
| Date Added to Maude | 2002-10-23 |
| 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 |
| Manufacturer Contact | AMY ROCHE |
| Manufacturer Street | 350 MASS AVENUE |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6175777270 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHA BONE SUBSTITUTE MATERIAL |
| Generic Name | ALPHA BONE SUBSTITUTE MATERIAL |
| Product Code | LMN |
| Date Received | 2002-10-21 |
| Model Number | 76-5010 |
| Catalog Number | 76-5010 |
| Lot Number | 100262 |
| ID Number | * |
| Device Expiration Date | 2002-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 412105 |
| Manufacturer | ETEX CORP. |
| Manufacturer Address | 350 MASS AVENUE CAMBRIDGE MA 02139 US |
| Baseline Brand Name | ALPHA BONE SUBSTITUTE MATERIAL |
| Baseline Generic Name | BONE SUBSTITUTE MATERIAL |
| Baseline Model No | 76-5010 |
| Baseline Catalog No | 76-5010 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-10-21 |