MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-05 for IFUSE IMPLANT SYSTEM 7035M-90 manufactured by Si-bone, Inc..
[177928722]
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 devices were out of specification. The most probable root cause is non-union of the implant in the si joint possibly related to the patient's poor health.
Patient Sequence No: 1, Text Type: N, H10
[177928723]
The patient had left side si joint arthrodesis in (b)(6) 2019 where three implants were installed. The patient had continued pain complaints after the initial procedure. The surgeon determined non-union of the inferior positioned implant possibly related to the patient's poor health (smoker). The surgeon did not indicate that any of the preexisting implants were malpositioned. In (b)(6) 2020, the surgeon performed a revision procedure where the inferior positioned implant was removed using chisels. The explant void was filled with bone graft. The status of the patient following the revision procedure is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2020-00003 |
| MDR Report Key | 9673046 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-04-11 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| Model Number | 7035M-90 |
| Lot Number | 2676701 |
| 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 | 2020-02-05 |