MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,08 report with the FDA on 2004-07-14 for BIO-TRANSFIX IMPLANT, 5MM X 50MM AR-1351LB manufactured by Arthrex, Inc..
[337963]
The bio-transfix implant broke in half post-op. Device was implanted during an anterior cruciate ligament (acl) procedure performed in 2002. Lateral pain started in 2003. The revision surgery occurred 5 months later. At the time of removal, the pt was noted to be fully healed. Follow up info obtained in 2004 revealed pt is in satisfactory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2004-00050 |
| MDR Report Key | 534099 |
| Report Source | 00,06,08 |
| Date Received | 2004-07-14 |
| Date of Event | 2003-11-13 |
| Date Mfgr Received | 2004-06-18 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2004-07-15 |
| 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, COORD |
| 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 |
| 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 | ACL RECONSTRUCTION - GRAFT FIXATION DEVICE |
| Product Code | MNU |
| Date Received | 2004-07-14 |
| Model Number | AR-1351LB |
| Catalog Number | AR-1351LB |
| Lot Number | 33208 |
| ID Number | NA |
| Device Expiration Date | 2004-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 523369 |
| 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 | 2004-07-14 |