MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-09 for ZEPF 52-400-00B/52-482-03 EB manufactured by Gebruder Zepf.
[5628619]
Kerrison#3 was used during a spinal case. The kerrison was attached to dura tissue and would not release. The dura tissue had to be cut away from the kerrison.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041425 |
| MDR Report Key | 4604324 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-03-09 |
| Date of Event | 2015-03-03 |
| Date Added to Maude | 2015-03-17 |
| 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 |
| 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 | ZEPF |
| Generic Name | KERRISON #3 |
| Product Code | HAD |
| Date Received | 2015-03-09 |
| Model Number | 52-400-00B/52-482-03 EB |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBRUDER ZEPF |
| Manufacturer Address | DURBHEIM, DE 78589 78589 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-09 |