MAUDE Adverse Event Report: IN2BONES, USA RTS; SILICONE TOE

Model Number M30 SE020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 12/15/2017

Event Type  Injury  

Event Description

It was reported through a retrospective clinical data review that a patient had an infection post-operatively after having an rts implant, requiring revision surgery.The surgeon noted that the patient was immunocompromised making her a higher risk for infection which caused the surgeon to explant the device.The device was discarded after explant.

• Brand Name: RTS
• Type of Device: SILICONE TOE
• Manufacturer (Section D): IN2BONES, USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES, USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer Contact: robert buchanan ; 6000 poplar avenue; suite 115; memphis, TN 38119 ; 9012607931
• MDR Report Key: 15676621
• MDR Text Key: 302469851
• Report Number: 3011580264-2022-00006
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2022
• Device Model Number: M30 SE020
• Device Lot Number: 223560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Female