MAUDE Adverse Event Report: SI-BONE, INC. IFUSE IMPLANT SYSTEM; ORTHOPEDIC ROD

Model Number SEE SECTION H.10

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 08/29/2014

Event Type  Injury  

Event Description

The surgeon attempted to remove the most cephalad si joint implant, but was unable to because the implant was solidly in bone.The implant was left in place.

• Brand Name: IFUSE IMPLANT SYSTEM
• Type of Device: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 3055 olin avenue; suite 2200; san jose CA 95128 206
• Manufacturer (Section G): SI-BONE, INC.; 3055 olin avenue; suite 2200; san jose CA 95128 206
• Manufacturer Contact: w. reckling, m.d. ; 3055 olin avenue; suite 2200; san jose, CA 95128-2066 ; 4082070700
• MDR Report Key: 4217394
• MDR Text Key: 5074134
• Report Number: 3007700286-2014-00107
• Device Sequence Number: 1
• Product Code: OUR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Other Device ID Number: EXP. DATES - SEE SECTION H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR