MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-13 for PRO OSTEON IMPLANT 5620 manufactured by Interpore Intl..
[22071678]
Implant was cultured prior to implant just after lid of product was opened. Sent to lab directly. Product was used in a 43 yr-old woman who underwent open reduction and internal fixation-tibial plateau left leg. On 2/6 surgeon was notified the specimen grew staphylococus epidermidis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 31673 |
| MDR Report Key | 31673 |
| Date Received | 1996-02-13 |
| Date of Report | 1996-02-07 |
| Date of Event | 1996-01-28 |
| Date Facility Aware | 1996-02-06 |
| Report Date | 1996-02-07 |
| Date Reported to FDA | 1996-02-12 |
| Date Added to Maude | 1996-04-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO OSTEON IMPLANT |
| Generic Name | PORE/BONE IMPLANT |
| Product Code | MBS |
| Date Received | 1996-02-13 |
| Catalog Number | 5620 |
| Lot Number | 512901, 505205 |
| Device Expiration Date | 1998-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32813 |
| Manufacturer | INTERPORE INTL. |
| Manufacturer Address | 181 TECHNOLOGY DR IRVINE CA 92718 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-02-13 |