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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 7035-90
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code Pain (1994)
Date of Event 09/27/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu and fmea, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause could not be determined.
 
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2011 where three implants were placed.The patient later presented to a new surgeon with pain complaints.The surgeon determined that the most caudal implant was too proud of the ilium and was irritating the surrounding tissue.In (b)(6) 2017, the surgeon performed a revision surgery where he removed the implant.
 
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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 Key6955285
Report Number3007700286-2017-00102
Device Sequence Number13730967
Product Code OUR
UDI-Device Identifier00859256003279
UDI-Public00859256003279
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 Year2011
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/12/2017
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 Date02/28/2014
Device Model Number7035-90
Device Lot Number3776-10023
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 09/27/2017
Initial Report FDA Received Date10/17/2017
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 Age72 YR
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