MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-08-26 for MACROPORE UNK manufactured by Medtronic Neurosurgery.
| Report Number | 2021898-2004-00106 |
| MDR Report Key | 949363 |
| Report Source | 05 |
| Date Received | 2004-08-26 |
| Date of Report | 2004-07-30 |
| Date Added to Maude | 2007-11-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8059681546 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MACROPORE |
| Generic Name | RESORBABLE PLYMER BONE FIXATION APPLIANCE |
| Product Code | MHI |
| Date Received | 2004-08-26 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 920953 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 93117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-08-26 |