MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,06,08 report with the FDA on 2014-03-12 for OPTIPLUG - UNK SIZE XXX-OPTIPLUG manufactured by Isotis Orthobiologics, Inc.
[4298607]
"a recent complaint concerning synplug and osteolysis resulted in a health hazard eval. This eval identified osteolysis as meeting the criteria of mdr reportable. A retrospective review has been conducted of our complaint management system resulting in the filing of this mdr".
Patient Sequence No: 1, Text Type: D, B5
[11572394]
An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090010-2014-00007 |
| MDR Report Key | 3687562 |
| Report Source | 03,06,08 |
| Date Received | 2014-03-12 |
| Date of Report | 2013-08-27 |
| Date Mfgr Received | 2014-02-20 |
| Date Added to Maude | 2014-03-20 |
| 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 | VIVIAN NELSON |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIPLUG - UNK SIZE |
| Generic Name | OPTIPLUG |
| Product Code | MBP |
| Date Received | 2014-03-12 |
| Catalog Number | XXX-OPTIPLUG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-12 |