MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for JULIET INSTRUMENTATION JUL-IO 00 01-N manufactured by Spineart Usa Inc.
[183925276]
Implant holder micro broke while md inserted and tried to place interbody device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9847806 |
| MDR Report Key | 9847806 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-12 |
| Report Date | 2020-02-18 |
| Date Reported to FDA | 2020-02-18 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | JULIET INSTRUMENTATION |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2020-03-18 |
| Model Number | JUL-IO 00 01-N |
| Catalog Number | JUL-IO 00 01-N |
| Lot Number | 3-4939 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEART USA INC |
| Manufacturer Address | 23332 MILL CREEK DR. SUITE 150 LAGUNA HILLS CA 92653 US 92653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |