MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for FITBONE TAA1140-F-205 60001383 manufactured by Wittenstein Intens Gmbh.
| Report Number | 3003236810-2020-00008 |
| MDR Report Key | 9887733 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-05-09 |
| Date Mfgr Received | 2019-05-09 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2020-03-27 |
| 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 | 3 |
| Manufacturer Contact | MRS. EVA LUNZ |
| Manufacturer Street | WALTER-WITTENSTEIN-STR. 1 |
| Manufacturer City | IGERSHEIM, BADEN-WUERTTEMBERG 97999 |
| Manufacturer Country | GM |
| Manufacturer Postal | 97999 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FITBONE |
| Generic Name | INTRAMEDULLARY LENGTHENING NAIL |
| Product Code | HSB |
| Date Received | 2020-03-27 |
| Model Number | TAA1140-F-205 |
| Catalog Number | 60001383 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WITTENSTEIN INTENS GMBH |
| Manufacturer Address | WALTER-WITTENSTEIN-STR. 1 IGERSHEIM, 97999 GM 97999 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |