MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-04 for DYNAMIC STIMULATION CLIP AND INLINE ACTIVATOR * 2012022 manufactured by Nuvasive Inc.
[18931238]
Nuvasive dynamic stimulation clip and inline activator was opened to the field. When the scrub tech attempted to clip to the instrument it was noticed that the clip was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4764985 |
| MDR Report Key | 4764985 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-05-04 |
| Date of Event | 2014-10-22 |
| Report Date | 2015-05-04 |
| Date Reported to FDA | 2015-05-04 |
| Date Reported to Mfgr | 2015-05-12 |
| Date Added to Maude | 2015-05-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC STIMULATION CLIP AND INLINE ACTIVATOR |
| Generic Name | ELECTRODE CORTICAL |
| Product Code | GYC |
| Date Received | 2015-05-04 |
| Model Number | * |
| Catalog Number | 2012022 |
| Lot Number | IM0027 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE INC |
| Manufacturer Address | 7475 LUSK BOULEVARD SAN DIEGO CA 92121 US 92121 |
| Brand Name | DYNAMIC STIMULATION CLIP AND INLINE ACTIVATOR |
| Generic Name | ELECTRODE CORTICAL |
| Product Code | GYC |
| Date Received | 2015-05-04 |
| Model Number | * |
| Catalog Number | 2012022 |
| Lot Number | IM0010 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE INC |
| Manufacturer Address | 7475 LUSK BOULEVARD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-04 |