MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-15 for BIOSCREW 7MM X 25MM C8011 manufactured by Linvatec Corp..
[27070]
Screw broke while in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009492 |
| MDR Report Key | 34162 |
| Date Received | 1996-07-15 |
| Date of Report | 1996-06-28 |
| Date of Event | 1996-06-10 |
| Date Added to Maude | 1996-07-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSCREW |
| Generic Name | ABSORBABLE SCREW |
| Product Code | MBJ |
| Date Received | 1996-07-15 |
| Model Number | 7MM X 25MM |
| Catalog Number | C8011 |
| Lot Number | 29546 |
| Device Expiration Date | 1997-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35522 |
| Manufacturer | LINVATEC CORP. |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 346434908 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-07-15 |