MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-04-06 for BIOPLEX C IMPLANT 2002-121408 manufactured by Interpore Cross Intl..
[409041]
Surgeon reported that the implant cracked during surgery, however the implant did not break apart. Note: the surgeon opted to leave the implant in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029012-2005-00011 |
| MDR Report Key | 589893 |
| Report Source | 05,07 |
| Date Received | 2005-04-06 |
| Date of Report | 2005-03-29 |
| Date of Event | 2005-01-10 |
| Date Mfgr Received | 2005-01-13 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-04-12 |
| 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 | MARY CARVAJAL |
| Manufacturer Street | 181 TECHNOLOGY DR |
| 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 | BIOPLEX C IMPLANT |
| Generic Name | CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2005-04-06 |
| Model Number | NA |
| Catalog Number | 2002-121408 |
| Lot Number | 405412 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 579742 |
| Manufacturer | INTERPORE CROSS INTL. |
| Manufacturer Address | * IRVINE CA * US |
| Baseline Brand Name | BIOPLEX IMPLANT |
| Baseline Generic Name | CEMENT RESTRICTOR |
| Baseline Catalog No | 2002-121408 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K023908 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-06 |