MAUDE Adverse Event Report: MPR WING RETRACTOR

Catalog Number 2153

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/16/2019

Event Type  Injury  

Event Description

The tip (pin) of the superior acetabular placed diamond wing retractor broke off in the patient's pelvic bone.Tip was left in situ due to risks of retrieval vs low potential for complications if left in place.Placement confirmed via imaging and patient has been educated.Medical products resource, us.Fda safety report id# (b)(4).

• Brand Name: MPR WING RETRACTOR
• Type of Device: RETRACTOR
• MDR Report Key: 10075675
• MDR Text Key: 191839736
• Report Number: MW5094610
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2153
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR