MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-13 for IFUSE IMPLANT SYSTEM 7055M-100 manufactured by Si-bone, Inc..
[180558508]
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; installing the implant too deep.
Patient Sequence No: 1, Text Type: N, H10
[180558509]
The patient had left side si joint arthrodesis in (b)(6) 2020 where three implants were installed. The patient complained of radicular pain following the initial procedure. The surgeon determined that the superior positioned implant had slightly breached the neuroforamen. Nine days after the initial procedure, the surgeon performed a revision procedure where he backed up the superior positioned implant a few millimeters but did not remove it. No other preexisting implants were adjusted or removed. The patient's radicular pain symptoms resolved following the revision procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2020-00011 |
| MDR Report Key | 9706166 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| Model Number | 7055M-100 |
| Lot Number | 2659061 |
| 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. Required No Informationntervention | 2020-02-13 |