MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU 8 HOLE STRAIGHT PLATE; PLATE, FIXATION, BONE

Model Number 73-1952

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 11/01/2019

Event Type  Injury  

Event Description

Surgeon implanted sternalock blu 8 hole plate as permanent fix for sternoclavicular ligaments reconstruction.Plate broke in the middle requiring surgery to remove.This plate is not indicated for this use per fda documentation.Fda safety report id# (b)(4).

• Brand Name: STERNALOCK BLU 8 HOLE STRAIGHT PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION
• MDR Report Key: 11530353
• MDR Text Key: 241554455
• Report Number: MW5100135
• Device Sequence Number: 1
• Product Code: HRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 73-1952
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 73