MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for IFUSE IMPLANT SYSTEM 7080M-90 manufactured by Si-bone, Inc..
[180556194]
Based on the information provided, review of the surgical technique guide, ifu, certificates of analysis and fmeas, there is no evidence that the device was out of specification. The event was procedural. The most probable root cause is the adult spinal deformity surgery procedure itself, not the si joint implant placement.
Patient Sequence No: 1, Text Type: N, H10
[180556195]
The elderly patient underwent a lengthy spinal deformity surgery including the bilateral installation of two si joint implants. The patient suffered extensive blood loss during the procedure. The patient coded on the table at the end of the case, was resuscitated then coded again without resuscitation. Medical opinion of chief medical officer: "the si joint implants and the portion of the overall surgical procedure to place the si joint implants are not related to patient mortality. The bleeding in this case (the primary causative factor) was a result of the spinal deformity surgery, including the spinal osteotomies. There is not typically a significant amount of bleeding associated with placement of s2ai screws with or without the concomitant placement of si joint implants. There was no significant bleeding reported in this case that was directly related to the placement of the si joint implants. When si joint implants are placed in conjunction with s2ai screws, it typically takes an additional 10 minutes per implant. This additional time is nominal compared to the many hours taken to perform the spinal deformity surgery. It is noted that the surgeon did revise the position of the s1 pedicle screws, the s2ai screws and the si joint implants. This did add additional time to the case. However, the revision of the s1 pedicle screws was in no way related to the placement of the si joint implants. The time to revise the s1 pedicle screws and the second o-arm spin would have been performed whether the si joint implants were placed or not. The initial position of the s2ai screws may or may not have been related to the subsequent placement of the si joint implants. In summary, adult spinal deformity surgery carries a high risk of morbidity and mortality. It is unlikely that the procedure to place si joint implants in conjunction with s2ai pelvic fixation in this case significantly increased the risk of bleeding or significantly lengthens the procedure. As such, placement of the si joint implants in this case or in spinal deformity cases in general is low risk and would, in most cases, be unrelated to morbidity associated with the spinal deformity surgery. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2020-00021 |
| MDR Report Key | 9745009 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2019-01-30 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2020-02-24 |
| 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 | 2070700328 |
| 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 | 2020-02-24 |
| Model Number | 7080M-90 |
| Lot Number | 2656281 |
| 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. Death | 2020-02-24 |