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 2020-02-05 for IFUSE IMPLANT SYSTEM 7045M-90 manufactured by Si-bone, Inc..
[178339709]
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 surgical procedure.
Patient Sequence No: 1, Text Type: N, H10
[178339710]
The surgeon was performing a right side si joint arthrodesis in (b)(6) 2020 when he noticed significant bleeding from the wound site. Bleeding was found by ir to be coming from the superior gluteal artery. The patient has a previously installed spinal cord stimulator in the right gluteal region. The surgeon used the aquamantys (hemostatic sealing device) to locate and cauterize the bleed. Blood loss was estimated to be around 1. 5 l. The patient received 2 units of rbcs in transfusion. The patient remained hemodynamically stable. The surgical incision was closed, and the patient was transferred to the hospital. The implant was left in place. No additional implants were placed. This is a case of vascular injury (a branch of the superior gluteal artery). It is unusual for a surgeon to experience this type of injury with placement of the most cephalad implant. The branches of the superior gluteal artery become smaller as they arborize in a cephalad direction in the gluteal musculature. This is a low frequency occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007700286-2020-00005 |
| MDR Report Key | 9673284 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-09-09 |
| 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 | 7045M-90 |
| Lot Number | 2692111 |
| 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. Hospitalization; 2. Other | 2020-02-05 |