MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-27 for KERRISON 7 IN 1MM FF771R manufactured by Aesculap Implant Systems, Llc.
[50528768]
Patient Sequence No: 1, Text Type: N, H10
[50528769]
The tip of a kerrison broke off in patient during use. The surgeon was able to remove the tip with the use of the microscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5825343 |
| MDR Report Key | 5825343 |
| Date Received | 2016-07-27 |
| Date of Report | 2016-07-25 |
| Date of Event | 2016-07-11 |
| Report Date | 2016-07-13 |
| Date Reported to FDA | 2016-07-13 |
| Date Reported to Mfgr | 2016-07-13 |
| Date Added to Maude | 2016-07-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERRISON |
| Generic Name | PUNCH, SURGICAL |
| Product Code | HAD |
| Date Received | 2016-07-27 |
| Model Number | 7 IN 1MM |
| Catalog Number | FF771R |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLANT SYSTEMS, LLC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-27 |