MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-12-03 for BIO-TRANSFIX IMPLANT, 5MM X 50MM AR-1351LB manufactured by Arthrex, Inc..
[312790]
Pt returned to doctor's office with swelling of medial side of leg. A mass was noted in the swelling. The distal portion of the implant was removed and acl was reported to be fine and stable. The pt is currently doing fine. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2004-00156 |
| MDR Report Key | 557481 |
| Report Source | 00 |
| Date Received | 2004-12-03 |
| Date of Report | 2004-12-03 |
| Date of Event | 2004-11-10 |
| Date Mfgr Received | 2004-11-19 |
| Date Added to Maude | 2004-12-06 |
| 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 | IVETT SOTOMAYOR, COORDINATOR |
| Manufacturer Street | 1370 CREEKSIDE BLVD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-TRANSFIX IMPLANT, 5MM X 50MM |
| Generic Name | GRAFT FIXATION DEVICE (ACL RECONSTRUCTION) |
| Product Code | MNU |
| Date Received | 2004-12-03 |
| Returned To Mfg | 2004-11-23 |
| Model Number | AR-1351LB |
| Catalog Number | AR-1351LB |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 547149 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | * NAPLES FL * US |
| Baseline Brand Name | BIO-TRANSFIX, 5 MM X 50 MM |
| Baseline Generic Name | GRAFT FIXATION DEVICE |
| Baseline Model No | AR-1351LB |
| Baseline Catalog No | AR-1351LB |
| Baseline ID | NA |
| Baseline Device Family | STAPLE, ABSORBABLE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K011172 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2004-12-03 |