MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-02 for IFUSE IMPLANT SYSTEM SEE SECTION H.10 manufactured by Si-bone, Inc..
[173647031]
Based on the information provided, review of the surgical technique manual, ifu, certificates of analysis and fmea, the most probable root cause is user error: improper implant positioning possibly caused by navigation errors. Part numbers, lot numbers, manufacturing dates, expiration dates and udi/gtin numbers: l 1st (superior): ifuse-3d implant, p/n 7065m-90, lot# 2666641, mfd. 03/11/19, exp. 2024-03-11, gtin (b)(4). R 1st (superior): ifuse-3d implant, p/n 7065m-90, lot# 2666641, mfd. 03/11/19, exp. 2024-03-11, gtin (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[173647032]
The patient had bilateral si joint arthrodesis in (b)(6) 2019 where two implants were installed on each side. The surgeon had difficulty using navigation during the procedure as the reference frames loosened. The patient reported leg pain after the initial procedure. The surgeon determined that the superior positioned implants on each side were malpositioned and impinging on the neuroforamen. Four days after the initial procedure, the surgeon performed a revision procedure where he removed the superior positioned implant on the right side and reinstalled it on the same side using a new trajectory. He then removed the superior positioned implant on the left side a replaced it with a shorter implant of the same type in a new position on the same side. The patient's radicular pain symptoms resolved following the revision procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2019-00160 |
| MDR Report Key | 9540369 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-02 |
| 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 | 2020-01-02 |
| Model Number | SEE SECTION H.10 |
| Lot Number | SEE SECTION H.10 |
| 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. Required No Informationntervention | 2020-01-02 |