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 OSETON 200 BONE GRAFT SUBSTITUTE C1057 manufactured by Interpore Cross International.
[17035480]
A non-interpore cross international spinal system construct was implanted into the pt. Pro osteon 200 bone graft substitute was also used in the surgery. X-rays showed that one of the three pro osteon 200 blocks and collapsed. When the surgeon opened up the pt, it was noticed that the screws from the spinal construct had "come out of the plate".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029012-2003-00002 |
| MDR Report Key | 438297 |
| Report Source | 08 |
| Date Received | 2003-01-17 |
| Date of Report | 2003-01-17 |
| Date of Event | 2003-01-01 |
| 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 OSETON 200 BONE GRAFT SUBSTITUTE |
| Generic Name | BONE GRAFT SUBSTITUTE |
| Product Code | LMN |
| Date Received | 2003-01-17 |
| Model Number | NA |
| Catalog Number | C1057 |
| Lot Number | 100907 |
| ID Number | NA |
| Device Expiration Date | 2005-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 427215 |
| 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 | C1057 |
| Baseline ID | NA |
| Baseline Device Family | POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTES |
| 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 |