MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number 7100-LP18-R

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

The reporter states that the surgeon observed that the fully-thread anti-drift bolt has pull through the plate further into the 1st metatarsal compared to the post-operative placement.Follow-up with the surgeon includes that the original implant date was in (b)(6) 2022 and the follow-up was (b)(6) 2022.The radiographic finding was identified at routine follow-up.The patient is asymptomatic, and the surgeon does not plan on revision surgery.It is unknown the lot numbers of the implants.After investigation, all potential lots of the plate and anti-draft bolt were reviewed.No non-conformances were identified.

Event Description

The reporter states that the surgeon observed that the fully-thread anti-drift bolt has pull through the plate further into the 1st metatarsal compared to the post-operative placement.Follow-up with the surgeon includes that the original implant date was in (b)(6) and the follow-up was (b)(6) 2022.The radiographic finding was identified at routine follow-up.The patient is asymptomatic, and the surgeon does not plan on revision surgery.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr.; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15255886
• MDR Text Key: 305525475
• Report Number: 3020584246-2022-00005
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K193452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2022

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 Model Number: 7100-LP18-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Prefer Not To Disclose