MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for IFUSE IMPLANT SYSTEM N/A 400230-B manufactured by Si-bone, Inc..
[185502008]
['si-bone cannulated impactor'] tip broke off while surgeon was using it [under c-arm viewing], surgeon immediately removed all pieces of broken item from patient. Surgeon completed another check under x-ray viewing as well as visual to verify all parts removed. Broken items placed in specimen bag and held for operating room manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897014 |
| MDR Report Key | 9897014 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-10 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | IFUSE IMPLANT SYSTEM |
| Generic Name | SACROILIAC JOINT FIXATION |
| Product Code | OUR |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 400230-B |
| Lot Number | 1007691 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SI-BONE, INC. |
| Manufacturer Address | 471 EL CAMINO REAL, SUITE 101 SANTA CLARA CA 95050 US 95050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |