MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-26 for CRANIOFIX 2 TITANIUM CLAMP 16MM FF491T manufactured by Aesculap Ag.
| Report Number | 9610612-2019-00517 |
| MDR Report Key | 8831590 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-26 |
| Date of Report | 2019-10-10 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2019-09-10 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2019-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRANIOFIX 2 TITANIUM CLAMP 16MM |
| Generic Name | CRANIAL CLOSUREGXN |
| Product Code | GXN |
| Date Received | 2019-07-26 |
| Model Number | FF491T |
| Catalog Number | FF491T |
| Lot Number | 52419664 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-26 |