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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SI-BONE, INC. IFUSE IMPLANT SYSTEM; ORTHOPEDIC ROD
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SI-BONE, INC. IFUSE IMPLANT SYSTEM; ORTHOPEDIC ROD Back to Search Results
Model Number 7045-90
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/24/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, certificates of analysis and fmea, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is incorrect pin placement leading to a malpositioned implant.
 
Event or Problem Description
In (b)(6) 2017, the surgeon was performing an si joint arthrodesis on the patient when the third implant was placed too anteriorly.Ct scans confirmed that the implant entered the abdomen but did not violate any major structures and it was removed intraoperatively.There were no post-op complications.
 
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Brand Name
IFUSE IMPLANT SYSTEM
Common Device Name
ORTHOPEDIC ROD
Manufacturer (Section D)
SI-BONE, INC.
3055 olin avenue
suite 2200
san jose CA 95128 2066
MDR Report Key6568911
Report Number3007700286-2017-00035
Device Sequence Number16331080
Product Code OUR
UDI-Device Identifier00859256003293
UDI-Public00859256003293
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K080398
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/23/2020
Device Model Number7045-90
Device Lot Number493856
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2017
Initial Report FDA Received Date05/16/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age41 YR
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