MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-06-17 for SCREW, CANNULATED DELTA AR-5035TB-10 AR-5035TB-10/AR-1351B manufactured by Arthrex, Inc..
[364869]
Pt experienced pain and swelling in knee. Revision surgery in 2004 from initial implant date 2003. Implant was removed. No inflammation noted at implant site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2004-00028 |
| MDR Report Key | 530122 |
| Report Source | 08 |
| Date Received | 2004-06-17 |
| Date of Report | 2004-04-16 |
| Date of Event | 2004-03-18 |
| Date Mfgr Received | 2004-03-18 |
| Date Added to Maude | 2004-06-18 |
| 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 | PEGGY COOLEY |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 2396435553 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREW, CANNULATED DELTA |
| Generic Name | BI0-SCREW |
| Product Code | MBJ |
| Date Received | 2004-06-17 |
| Returned To Mfg | 2004-04-20 |
| Model Number | AR-5035TB-10 |
| Catalog Number | AR-5035TB-10/AR-1351B |
| Lot Number | 34277 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 519350 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BLVD. NAPLES FL 341081945 US |
| Baseline Brand Name | SCREW, CANNULATED DELTA |
| Baseline Generic Name | BI0-SCREW |
| Baseline Model No | AR-5035TB-10 |
| Baseline Catalog No | AR-5035TB-10/AR-1351B |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-06-17 |