MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-22 for INTEGRA NEURO SCIENCES manufactured by .
[19460350]
After the mayfield pin placement and pt positioning, the md was attaching the stealth elbow, the md noticed and made a comment that the mayfield was wiggling too much. Upon examination of the whole mayfield frame, the md found that the distal part had a crack and was breaking. The md immediately held the pt's head and called for assistance. While unlocking the mayfield, the device broke into two. Dates of use: (b) (6) 2010 - (b) (6) 2010.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015679 |
| MDR Report Key | 1668690 |
| Date Received | 2010-04-22 |
| Date of Report | 2010-04-22 |
| Date of Event | 2010-04-20 |
| Date Added to Maude | 2010-04-30 |
| 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 | RISK MANAGER |
| 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 | INTEGRA NEURO SCIENCES |
| Generic Name | MAYFIELD HEADREST |
| Product Code | HBM |
| Date Received | 2010-04-22 |
| ID Number | A-2008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-04-22 |