MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for IFUSE IMPLANT SYSTEM 7040-100 manufactured by Si-bone, Inc..
[187855712]
Based on the information provided, review of the surgical technique manual, ifu and fmeas, the most probable root cause is user error; malpositioning of the initial implant and improper implant size selection, using too short of an implant.
Patient Sequence No: 1, Text Type: N, H10
[187855713]
The patient had si joint arthrodesis in (b)(6) 2014 where two implants were installed. The patient had a period of pain relief but later reported to a different surgeon with complaints of a recurrence of si joint pain. The surgeon determined that the cranial positioned implant was malpositioned and loose. In (b)(6) 2020, the surgeon performed a revision surgery where he removed the cranial positioned implant and replaced it with a larger implant of the same type. An additional implant was also installed to help fixate the si joint. The patient's joint appears to be better stabilized with less pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2020-00031 |
| MDR Report Key | 9905463 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2070700 |
| Manufacturer G1 | SI-BONE, INC. |
| Manufacturer Street | 471 EL CAMINO REAL SUITE 101 |
| Manufacturer City | SANTA CLARA, CA |
| Manufacturer Country | US |
| 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 | 2020-03-31 |
| Model Number | 7040-100 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |