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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 7050-90
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code Undesired Nerve Stimulation (1980)
Date of Event 11/02/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, certificates of conformance 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 improper implant size selection.
 
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2017 where three implants were placed.The patient reported radicular pain following the procedure.The surgeon determined that the most cranial positioned implant was impinging on the nerve root.The surgeon performed a revision procedure the day after the initial surgery where he removed the implant.The patient's pain resolved.
 
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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 Key7064171
Report Number3007700286-2017-00126
Device Sequence Number13916287
Product Code OUR
UDI-Device Identifier00859256003309
UDI-Public00859256003309
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 company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/20/2017
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 Date04/19/2022
Device Model Number7050-90
Device Lot Number493888
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/02/2017
Initial Report FDA Received Date11/28/2017
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 Required Intervention;
Patient Age41 YR
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