MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-12-12 for ALLOGENIX PUTTY * 02-3110 manufactured by Interpore Cross.
[20162093]
Tumor resection. Allogenix implanted (2006) in craniotomy cut lines and around the thinflap plates. Several days later, patient became lethargic. Doctor found fluid build up, what appeared to be pus. Culture proved to be infection. Removed remaining allogenix, debrided, irrigated and closed.
Patient Sequence No: 1, Text Type: D, B5
[20447036]
Additional information has been requested from facility (hospital) but has not been received at this time. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1032347-2006-00039 |
| MDR Report Key | 794674 |
| Report Source | 05 |
| Date Received | 2006-12-12 |
| Date of Report | 2006-11-15 |
| Date of Event | 2006-11-11 |
| Date Mfgr Received | 2006-11-15 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-12-18 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONSVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047419468 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLOGENIX PUTTY |
| Generic Name | DEMINERALIZED BONE |
| Product Code | LMO |
| Date Received | 2006-12-12 |
| Model Number | * |
| Catalog Number | 02-3110 |
| Lot Number | 198722 |
| ID Number | * |
| Device Expiration Date | 2007-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 782295 |
| Manufacturer | INTERPORE CROSS |
| Manufacturer Address | * IRVINE CA * US |
| Baseline Brand Name | ALLOGENIX PUTTY |
| Baseline Generic Name | DEMINERALIZED BONE |
| Baseline Model No | * |
| Baseline Catalog No | 02-3110 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-12-12 |