MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-07 for IFUSE IMPLANT SYSTEM SEE SECTION H.10 manufactured by Si-bone, Inc..
[174292966]
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; implant malpositioning during installation. Part numbers, lot numbers, manufacturing dates, expiration dates and udi/gtin numbers: 1st (superior): ifuse implant, p/n 7055-100, lot# 493439, mfd. 16 jul 15, exp. 2020-07-16, gtin (b)(4). 2nd (middle): ifuse implant, p/n 7050-100, lot# 493438, mfd. 24 jul 15, exp. 2020-07-24, gtin (b)(4). 3rd (inferior): ifuse implant, p/n 7040-100, lot# 493436, mfd. 30 jul 15, exp. 2020-07-30, gtin (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174292967]
The patient had right side si joint arthrodesis in (b)(6) 2016 where three implants were installed. The patient had pain relief for one year after the initial procedure before reporting a recurrence of right si joint pain symptoms to a new surgeon who determined that all the implants were slightly malpositioned dorsally. The surgeon did not indicate that any of the implants were loose. In (b)(6) 2019, the surgeon performed a revision surgery where he removed the implants with chisels. The status of the patient following the revision procedure is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2019-00158 |
| MDR Report Key | 9558704 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-07 |
| 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 | 2020-01-07 |
| 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 | 2020-01-07 |