MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-07-31 for BIOPLEX C IMPLANT 2002-121408 manufactured by Ebi, L.p..
[905096]
It was reported that the bioplex c implant fractured in 3 places during implantation. The implant was removed and discarded. Patient status is fine.
Patient Sequence No: 1, Text Type: D, B5
[7885890]
The dhr for the reported device was reviewed, and no discrepancies were observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242816-2008-00106 |
| MDR Report Key | 1084149 |
| Report Source | 07 |
| Date Received | 2008-07-31 |
| Date of Report | 2008-07-18 |
| Date of Event | 2008-07-09 |
| Date Mfgr Received | 2008-07-18 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2008-08-01 |
| 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 | MR. ART KAUFMAN |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer G1 | EBI, L.P. |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPLEX C IMPLANT |
| Generic Name | PROSTHESIS, HIP, CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2008-07-31 |
| Catalog Number | 2002-121408 |
| Lot Number | 780120 |
| Device Expiration Date | 2009-12-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1049429 |
| Manufacturer | EBI, L.P. |
| Manufacturer Address | 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-31 |