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 2004-06-17 for SCREW, BIO INTERFERENCE AR-1390TB manufactured by Arthrex, Inc..
[19248160]
The tip of the implant broke off 3 months post-op.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2004-00023 |
| MDR Report Key | 530097 |
| Report Source | 05,06,07 |
| Date Received | 2004-06-17 |
| Date of Report | 2004-04-16 |
| Date of Event | 2004-03-03 |
| Date Mfgr Received | 2004-03-04 |
| Date Added to Maude | 2004-06-18 |
| 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 | PEGGY COOLEY |
| Manufacturer Street | 1370 CREEKSIDE BLVD |
| Manufacturer City | NAPLES FL 34108 |
| Manufacturer Country | US |
| Manufacturer Postal | 34108 |
| Manufacturer Phone | 2396435553 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREW, BIO INTERFERENCE |
| Generic Name | BIOABSORBABLE FIXATION DEVICE |
| Product Code | MBJ |
| Date Received | 2004-06-17 |
| Model Number | AR-1390TB |
| Catalog Number | AR-1390TB |
| Lot Number | 38519 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 519325 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BLVD NAPLES FL 34108 US |
| Baseline Brand Name | SCREW, BIO INT. |
| Baseline Generic Name | BIOABSORBABLE FIXATION DEVICE |
| Baseline Model No | AR-1390TB |
| Baseline Catalog No | AR-139OTB |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-17 |