MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-10 for IFUSE IMPLANT SYSTEM SEE SECTION H.10 manufactured by Si-bone, Inc..
[180556976]
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 incorrect diagnosis. It was the surgeon's decision to remove the implants at the patient's request. Part numbers, lot numbers, expiration dates and udi/gtin numbers: 1st (superior): ifuse implant, p/n 7050-100, lot# 494222, mfd. 19 aug 2017, exp. 2022-08-19, gtin (b)(4). 2nd (second): ifuse implant, p/n 7040-100, lot# 493996, mfd. 30 aug 2017, exp. 2022-08-30, gtin (b)(4). 3rd (inferior): ifuse implant, p/n 7040-100, lot# 493996, mfd. 30 aug 2017, exp. 2022-08-30, gtin (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[180556977]
The patient had left side si joint arthrodesis in (b)(6) 2018 where three implants were installed. The patient claims to have never had pain relief following the initial procedure and wanted the implants removed. The patient had no radicular pain symptoms and the surgeon believes the implants were well positioned and not loose. It is likely that it was an incorrect diagnosis. In (b)(6) 2020, the surgeon performed a revision procedure where he removed all three implants using chisels. The explant voids were not filled with bone graft or other hardware. The status of the patient following the revision procedure is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2020-00006 |
| MDR Report Key | 9690484 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-10 |