NUVASIVE RELINE SYSTEM Adverse Event — Malfunction (MDR 2031966-2020-00082)
NUVASIVE RELINE SYSTEM Adverse Event — Malfunction (MDR 2031966-2020-00082) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NUVASIVE RELINE SYSTEM; Generic name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM; Manufacturer: NUVASIVE INC.
| Device | NUVASIVE RELINE SYSTEM |
|---|---|
| Generic name | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
| Manufacturer | NUVASIVE INC |
| Report number | 2031966-2020-00082 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. X-RAY FILMS PROVIDED CONFIRM THE ALLEGED EVENT. EVEN THOUGH ROOT CAUSE CANNOT BE CONFIRMED, PHYSICIAN INDICATED NON-UNION MAY HAVE CONTRIBUTED TO ALLEGED EVENT. LABELING REVIEW: "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LO |
| Source | openFDA MAUDE (device adverse events) |
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