MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07,08 report with the FDA on 2005-08-19 for BIO-TRANSFIX, 5MM X 50MM AR-1351LB manufactured by Arthrex, Inc..
[386144]
This is the third patient of three who presented with a post-op infection. Patients tested positive for staphylococcus. All three events involve the same surgeon, at the same facility with the same part / lot number. The customer is not sure where the infection came from. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2005-00135 |
| MDR Report Key | 628362 |
| Report Source | 00,01,07,08 |
| Date Received | 2005-08-19 |
| Date of Report | 2005-08-05 |
| Date of Event | 2005-07-01 |
| Date Mfgr Received | 2005-07-21 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2005-08-22 |
| 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, SENIOR 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 | 2005-08-19 |
| Model Number | AR-1351LB |
| Catalog Number | AR-1351LB |
| Lot Number | 57616 |
| ID Number | NA |
| Device Expiration Date | 2007-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 617992 |
| 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. Required No Informationntervention | 2005-08-19 |