MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for PUMA SYSTEM manufactured by Panther Orthopedics, Inc..
[143999074]
Patient called to report an adverse event involving her puma system device, which was implanted on (b)(6) 2018. Patient stated that the device worked well for her and helped her heal appropriately, however, she saw on x-ray that the device was fractured. Patient stated that her physician decided to leave the broken device implanted in her. Patient states she felt it was important to make fda aware of this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086341 |
| MDR Report Key | 8573904 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date of Event | 2018-11-21 |
| Date Added to Maude | 2019-05-02 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PUMA SYSTEM |
| Generic Name | WASHER, BOLT, NUT |
| Product Code | HTN |
| Date Received | 2019-05-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PANTHER ORTHOPEDICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |