MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for OSCAR OE3000B/1 manufactured by Orthofix Srl.
[125767057]
Information provided states that during a case the pierce/probe would not tune to frequency. During the removal of the cement the generator would work only intermittently. The case was completed successfully using the generator. This resulted in a delay in the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183449-2018-00032 |
| MDR Report Key | 8026632 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-09-25 |
| Date Facility Aware | 2018-10-01 |
| Report Date | 2018-10-30 |
| Date Reported to Mfgr | 2018-10-30 |
| Date Added to Maude | 2018-10-31 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSCAR |
| Generic Name | GENERATOR CASEFRAME NON-OPTICAL |
| Product Code | LZV |
| Date Received | 2018-10-31 |
| Model Number | OE3000B/1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI 9 BUSSOLENGO, VERONA 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-31 |