MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-06 for IFUSE IMPLANT SYSTEM UNKNOWN manufactured by Si-bone, Inc..
[173969317]
Based on the information provided, review of the surgical technique manual, ifu, certificates of analysis and fmeas, there is no indication of device failure and no indication that the device was out of specification. The most probable root cause is user error; malpositioning of the implant during installation and/or improper implant size selection, using too short of an implant.
Patient Sequence No: 1, Text Type: N, H10
[173969318]
The patient had left side si joint arthrodesis in (b)(6) 2019 where two implants were placed. The patient later reported continued left si joint pain. The surgeon determined that the caudal positioned implant was malpositioned, too dorsal, and was not fully across the si joint. The surgeon did not indicate that any of the implants were loose. In (b)(6) 2019, the surgeon performed a revision surgery where he removed the caudal implant with chisels as it was solidly fixed in bone. He also installed a new implant of the same type in a more caudal position. The patient is doing well following the revision procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2019-00157 |
| MDR Report Key | 9555398 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2020-01-06 |
| 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 | W. RECKLING, M.D. |
| Manufacturer Street | 471 EL CAMINO REAL SUITE 101 |
| Manufacturer City | SANTA CLARA CA 950504482 |
| Manufacturer Country | US |
| Manufacturer Postal | 950504482 |
| Manufacturer Phone | 4082070700 |
| Manufacturer G1 | SI-BONE, INC. |
| Manufacturer Street | 471 EL CAMINO REAL SUITE 101 |
| Manufacturer City | SANTA CLARA CA 950504482 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 950504482 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IFUSE IMPLANT SYSTEM |
| Generic Name | ORTHOPEDIC ROD |
| Product Code | OUR |
| Date Received | 2020-01-06 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SI-BONE, INC. |
| Manufacturer Address | 471 EL CAMINO REAL SUITE 101 SANTA CLARA CA 950504482 US 950504482 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-06 |