MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-07-25 for PAPAVERO-CASPAR SPEC SLIM-PROF 80X11MM FF589R manufactured by Aesculap Ag & Co. Kg.
[876569]
The opening screw stripped while in the patient and had to be cut out with the drill. No patient injury. Surgery was delayed for twenty minutes.
Patient Sequence No: 1, Text Type: D, B5
[7887025]
Device is being held at the user facility as per their policy. Aesculap, inc has attempted contact with the facility in order to facilitate release of the device for evaluation. Once released, item will be forwarded to the manufacturing site for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2008-00017 |
| MDR Report Key | 1082143 |
| Report Source | 06,07 |
| Date Received | 2008-07-25 |
| Date of Report | 2008-07-23 |
| Date of Event | 2008-06-13 |
| Date Mfgr Received | 2008-06-26 |
| Date Added to Maude | 2009-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR. |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG & CO. KG |
| Manufacturer Street | P.O. 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 | PAPAVERO-CASPAR SPEC SLIM-PROF 80X11MM |
| Product Code | EPY |
| Date Received | 2008-07-25 |
| Model Number | FF589R |
| Catalog Number | FF589R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN DE 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-25 |