MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for KERRISON RONGUER FK927B 3119 manufactured by Aesculap, Inc.
[86119571]
Patient Sequence No: 1, Text Type: N, H10
[86119572]
It was noticed that the head of the screw on the ejector tip kerrison was missing. The nurse was unable to find the screw so flat plate x-ray done to rule out retained foreign object (rfo). Xray confirmed no rfo.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6864483 |
| MDR Report Key | 6864483 |
| Date Received | 2017-09-14 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-07-26 |
| Report Date | 2017-08-14 |
| Date Reported to FDA | 2017-08-14 |
| Date Reported to Mfgr | 2017-08-14 |
| Date Added to Maude | 2017-09-14 |
| 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 RONGUER |
| Generic Name | AESCULAP KERRISON RONGUER |
| Product Code | KBB |
| Date Received | 2017-09-14 |
| Model Number | FK927B |
| Catalog Number | 3119 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-14 |