MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-07 for NUVASIVE? VERSATIE SYSTEM 8550002 manufactured by Nuvasive, Inc..
[91292280]
No product has been returned for investigation, nor were radiographs provided to confirm the reported event. Labeling review: "as with any major surgical procedures, there are risks involved in orthopedic surgery... " "potential risks identified with the use of this system, which may require additional surgery, include: implants cutting through soft osteoporotic, osteolienic or cancellous bone... " no product returned.
Patient Sequence No: 1, Text Type: N, H10
[91292281]
Information received states laminar band sawed through bone tissue. No other event information has been provided or radiographs that confirm the reported event. No revision procedure was reported.
Patient Sequence No: 1, Text Type: D, B5
[133264316]
Received information stating lamina breakage was unrelated to product malfunction. Posterior fixation was applied and laminectomy was completed. No revision procedure was required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031966-2017-00163 |
| MDR Report Key | 7007365 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-07 |
| Date of Report | 2018-02-09 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2018-01-08 |
| Date Added to Maude | 2017-11-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. YOBANA SANCHEZ |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589093383 |
| Manufacturer G1 | NUVASIVE, INC. |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE? VERSATIE SYSTEM |
| Generic Name | BONE FIXATION CERCLAGE, SUBLAMINAR |
| Product Code | OWI |
| Date Received | 2017-11-07 |
| Model Number | 8550002 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-07 |