MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-01-17 for PRO OSTEON 200 BONE GRAFT SUBSTITUTE C1059 manufactured by Interpore Cross International.
[19239077]
Pt had undergone a 1-level fusion in 2002, which involved pro osteon 200 bone graft substitute. Post-operatively, the pt fell on their buttocks. X-rays showed that the pro osteon 200 block had collapsed. It is not known if the pt's fall caused the collapse of the pro osteon 200 block. When the block collapsed, it pushed the graft material near the spinal cord.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029012-2003-00001 |
| MDR Report Key | 438265 |
| Report Source | 08 |
| Date Received | 2003-01-17 |
| Date of Report | 2003-01-16 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2002-12-18 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2003-01-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CAROL BERARD |
| Manufacturer Street | 181 TECHNOLOGY DRIUE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494533200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO OSTEON 200 BONE GRAFT SUBSTITUTE |
| Generic Name | BONE GRAFT SUBSTITUTE |
| Product Code | LMN |
| Date Received | 2003-01-17 |
| Model Number | NA |
| Catalog Number | C1059 |
| Lot Number | 100907 |
| ID Number | NA |
| Device Expiration Date | 2005-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 427183 |
| Manufacturer | INTERPORE CROSS INTERNATIONAL |
| Manufacturer Address | 181 TECHNOLOGY DRIVE IRVINE CA 92618 US |
| Baseline Brand Name | PRO OSTEON 200 BONE GRAFT SUBSTITUTE |
| Baseline Generic Name | ENDOSSEOUS IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | C1059 |
| Baseline ID | NA |
| Baseline Device Family | POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K822420 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2003-01-17 |