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 TAA1180-T-245 60001348 manufactured by Wittenstein Intens Gmbh.
[188261611]
The event problem and evaluation codes were only chosen according to the surgeons event report. The codes will become more specific after investigation.
Patient Sequence No: 1, Text Type: N, H10
[188261612]
Distraction of the tibia implant stopped. Pulses on the control set were initiated, but the audible response was absent. Radiologically the incomplete distraction was confirmed. According to the patient's wishes, the femoral implant is lengthened to 6 cm instead of 4 cm to compensate the undercorrection of the tibia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003236810-2020-00011 |
| MDR Report Key | 9887779 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2018-03-29 |
| 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 | TAA1180-T-245 |
| Catalog Number | 60001348 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |