MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-02 for OPTIPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics Inc..
| Report Number | 2090010-2019-00004 |
| MDR Report Key | 8858056 |
| Date Received | 2019-08-02 |
| Date of Report | 2019-08-02 |
| Date of Event | 2019-05-18 |
| Date Added to Maude | 2019-08-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIPLUG CEMENT RESTRICTOR |
| Generic Name | CEMENT OBTURATOR |
| Product Code | LZN |
| Date Received | 2019-08-02 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS INC. |
| Manufacturer Address | 2 GOODYEAR 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-02 |