MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-04-17 for PRO OSTEON 500 2RG05 manufactured by Ebi, L.p..
[16169900]
It was reported that pro osteon 500 was implanted in 2002 for cervical fusion, and that the pt is currently experiencing pelvic pain.
Patient Sequence No: 1, Text Type: D, B5
[16205022]
Dhr review showed that the reported part # /lot# met all applicable specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242816-2008-00054 |
| MDR Report Key | 1030808 |
| Report Source | 05,06 |
| Date Received | 2008-04-17 |
| Date of Report | 2008-04-11 |
| Date of Event | 2008-04-09 |
| Date Mfgr Received | 2008-04-11 |
| Date Added to Maude | 2008-08-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ART KAUFMAN, SR DIR |
| Manufacturer Street | 100 INTERPACE PKWY. |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO OSTEON 500 |
| Product Code | MBS |
| Date Received | 2008-04-17 |
| Catalog Number | 2RG05 |
| Lot Number | 202302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, L.P. |
| Manufacturer Address | PARSIPPANY NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-17 |