MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-07-06 for BIO-TRANSFIX, 5MM X 50MM AR-1351LB manufactured by Arthrex, Inc..
[426329]
Over the last 3 days, patient has developed a skin breakdown over a pretibial cystin left knee. Preop aspiration culture demonstrated no growth. A portion of the acl graft was found torn. All hardware was removed from the patient. Part number referenced in this report needs to be confirmed by hospital. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2005-00103 |
| MDR Report Key | 619422 |
| Report Source | 08 |
| Date Received | 2005-07-06 |
| Date of Report | 2005-07-01 |
| Date of Event | 2005-05-30 |
| Date Mfgr Received | 2005-06-07 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2005-07-07 |
| 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 | IVETTE SOTOMAYOR, SR ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-TRANSFIX, 5MM X 50MM |
| Generic Name | GRAFT FIXATION DEVICE |
| Product Code | MNU |
| Date Received | 2005-07-06 |
| Model Number | AR-1351LB |
| Catalog Number | AR-1351LB |
| Lot Number | 41009 |
| ID Number | NA |
| Device Expiration Date | 2009-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 609110 |
| 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 | 2005-07-06 |