MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-25 for IFUSE IMPLANT SYSTEM SEE SECTION H.10 manufactured by Si-bone, Inc..
[180795581]
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 short or not installing the implant deep enough. Part numbers, lot numbers, expiration dates and udi/gtin numbers: 2nd (second): ifuse implant, p/n 7030-90, lot# 7628002578001, mfd. 07/07/11, exp. 2014-07-07, (b)(4); 3rd (inferior): ifuse implant, p/n 7035-90, lot# 7628002578002, mfd. 07/06/11, exp. 2014-07-06, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[180795582]
The patient had right side si joint arthrodesis in (b)(6) 2011 where three implants were installed. The patient had a period of pain relief before reporting a recurrence of si joint pain symptoms. The surgeon determined that the second and third positioned implants were not fully across the si joint. The surgeon did not indicate that any of the implants were loose. In (b)(6) 2020, the surgeon removed the second and third implants using chisels as they were solidly fixed in bone. He then installed a new implant of the same type in a more anterior position to help fixate the si joint. No other preexisting implants were adjusted or removed. The patient is doing well following the revision procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2020-00014 |
| MDR Report Key | 9750847 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-25 |
| 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 | 2020-02-25 |
| 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 | 2020-02-25 |