MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-27 for STAYFUSE FUSION DEVICE 2227-02-1 2227-02-01 manufactured by Zimmer, Inc..
[571408]
Customer service was notified that a stayfuse device was removed by a dr.
Patient Sequence No: 1, Text Type: D, B5
[7915943]
Stayfuse was distributed by zimmer until 12/1/05. At that time, nexa took over mfg and distribution. Stayfuse imp consists of two components: a proximal device and a distal device. Both components from this procedure are listed. Add'l model number 2227-04-04. Add'l catalog number 2227-04-04. Add'l lot number 77091338.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2030833-2006-00011 |
| MDR Report Key | 789405 |
| Report Source | 05,06 |
| Date Received | 2006-11-27 |
| Date of Report | 2006-11-27 |
| Date Mfgr Received | 2006-09-21 |
| Date Added to Maude | 2006-12-05 |
| 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 Street | 10675 SORRENTO VALLEY RD #100 |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588660660 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAYFUSE FUSION DEVICE |
| Generic Name | INTERPHALANGEAL FUSION DEVICE |
| Product Code | LZJ |
| Date Received | 2006-11-27 |
| Model Number | 2227-02-1 |
| Catalog Number | 2227-02-01 |
| Lot Number | 77091323 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 777083 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | * WARSAW IN * US |
| Baseline Brand Name | STAYFUSE FUSION DEVICE |
| Baseline Generic Name | INTERPHALANGEAL FUSION DEVICE |
| Baseline Model No | 2227-02-1 |
| Baseline Catalog No | 2227-02-01 |
| Baseline ID | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-27 |