MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-02-25 for BIOPLEX IMPLANT 2002-121408 manufactured by Ebi.
[795127]
It was reported that post-op x-ray of a cervical fusion indicated that the bioplex has cracked. During 2008 revision surgery, the surgeon observed that the bioplex broke down quickly for a 3 month timeframe. Revision surgery was completed.
Patient Sequence No: 1, Text Type: D, B5
[7945766]
The package insert indicates, "this device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242816-2008-00016 |
| MDR Report Key | 1003021 |
| Report Source | 07 |
| Date Received | 2008-02-25 |
| Date of Report | 2008-01-30 |
| Date of Event | 2008-01-23 |
| Date Mfgr Received | 2008-01-30 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2008-02-29 |
| 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 DIRECTOR |
| 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 | BIOPLEX IMPLANT |
| Product Code | JDK |
| Date Received | 2008-02-25 |
| Catalog Number | 2002-121408 |
| Lot Number | 600479 |
| Device Expiration Date | 2008-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 971882 |
| Manufacturer | EBI |
| Manufacturer Address | PARSIPPANY NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-25 |