MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-20 for NUVASIVE NVM5 SYSTEM 2010014006 manufactured by Nuvasive, Inc..
[90696483]
No product has been returned for evaluation. Labeling review: "proper handling, insertion and placement of electrodes is critical for emg monitoring. Needles should be at least 1" apart... " "precaution: proper handling, insertion, and placement of needle electrodes is critical for accurate monitoring... " "precaution: improperly placed or bent needles increase the risk of the needle breaking off in the patient... " "precaution: do not attempt to straighten bent needles because this may cause stress and weaken the needle causing it to break off in the patient... " "precaution: needles are sharp nd extreme care must be taken during handling... "
Patient Sequence No: 1, Text Type: N, H10
[90696484]
During an extreme lateral interbody fusion procedure the nvm5 detected signal interference. Electrode placement was inspected and found a needle brakeage. A needle electrode was placed and surgical procedure continued. Post-operatively a 2 cm incision was performed to remove the broken needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2017-00147 |
| MDR Report Key | 6967146 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-26 |
| Date Added to Maude | 2017-10-20 |
| 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 | 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 NVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2017-10-20 |
| Model Number | 2010014006 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-20 |