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 7065M-100 manufactured by Si-bone, Inc..
[173446633]
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; improper implant size selection, using an implant that was too long or placing the implant too deep.
Patient Sequence No: 1, Text Type: N, H10
[173446634]
The patient had right side si joint arthrodesis in (b)(6) 2019 where three implants were installed. The patient complained of radicular pain following the procedure. The surgeon determined that there was a bone fragment caused by the installation of the superior positioned implant that may have been compressing the nerve in the neuroforamen in the s1 position. In (b)(6) 2019, a different surgeon removed the superior positioned implant and placed bone graft in the explant void. 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 | 3007700286-2019-00155 |
| MDR Report Key | 9539251 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2018-02-16 |
| 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 | 7065M-100 |
| Lot Number | 2628271 |
| 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 |