MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-23 for SPIKE PUSHER 390.71 manufactured by Synthes.
[5237886]
Patient underwent insertion of a trochanteric fixation nail for fractured hip. Ball spike pushers were used to help reduce the fracture. Upon removal of the spike pusher, the clip dislodged in the patient's fascia. Final fluoroscopy done in the operating room was negative for retained clip per physician. Routine post operative films of the hip obtained in pacu showed the clip from the ball spiker pusher was retained. Removal of clip was done on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039841 |
| MDR Report Key | 4375356 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-23 |
| Date of Event | 2014-12-15 |
| Date Added to Maude | 2015-01-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIKE PUSHER |
| Generic Name | SPIKE PUSHER |
| Product Code | HXO |
| Date Received | 2014-12-23 |
| Model Number | 390.71 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-23 |