MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-26 for TRIMAX 18MM PREP KIT TriMAX 18mm Prep Kit 7300-1800KT manufactured by Crossroads Extremity Systems.
| Report Number | 3011421599-2020-00003 |
| MDR Report Key | 9756846 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-12-06 |
| Date Added to Maude | 2020-02-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 6055 PRIMACY PARKWAY STE 140 |
| Manufacturer City | MEMPHIS, TN |
| Manufacturer Country | US |
| Manufacturer Phone | 2218406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIMAX 18MM PREP KIT |
| Generic Name | STAPLE, FIXATION, BONE |
| Product Code | JDR |
| Date Received | 2020-02-26 |
| Model Number | TriMAX 18mm Prep Kit |
| Catalog Number | 7300-1800KT |
| Lot Number | 500917 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSROADS EXTREMITY SYSTEMS |
| Manufacturer Address | 6055 PRIMACY PARKWAY STE 140 MEMPHIS, TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-26 |