MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-12-01 for BIO-TRANFIX, 5MM X 50MM AR-1351LB manufactured by Arthrex, Inc..
[572397]
Pt presented with pain and swelling at insertion site after anterior cruciate ligament repair. Culture showed staph epidermidis present. Pt was administered vancomycin to treat the infection. Pt is to follow up with his general doctor. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8054374]
It is unk if the implant was removed from the pt. Dhr review revealed no issues with the sterilization of this product. Staph epidermidis is a common inhabitant of the skin. Infections reported with this organism are typically acquired in the hosp mainly through skin wounds and/or indwelled catheters. There are no other complaints for this part / lot number combination. This event is not considered a product related issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2006-00176 |
| MDR Report Key | 789997 |
| Report Source | 05,06,07 |
| Date Received | 2006-12-01 |
| Date of Report | 2006-11-29 |
| Date of Event | 2006-11-14 |
| Date Mfgr Received | 2006-11-14 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2006-12-06 |
| 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 | IVETTE GALMEZ, SR MDR |
| 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-TRANFIX, 5MM X 50MM |
| Generic Name | BIO-ABSORBABLE FIXATION DEVICE |
| Product Code | MNU |
| Date Received | 2006-12-01 |
| Model Number | NA |
| Catalog Number | AR-1351LB |
| Lot Number | 97993 |
| ID Number | NA |
| Device Expiration Date | 2008-03-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 777675 |
| 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 | 2006-12-01 |