MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE PLATE; PLATE, FIXATION, BONE

Model Number AR-2652 CL

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Malunion of Bone (4529)

Event Date 01/12/2021

Event Type  Injury  

Event Description

Patient had left clavicle mal union on (b)(6) 2020.Patient felt a pop post operatively while driving and lifting his arm.Was seen immediately by the surgeon and was noted to have a failed plate which had fractured at the previous fracture site.Patient had revision surgery on (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: CLAVICLE PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 11207345
• MDR Text Key: 228200153
• Report Number: MW5098899
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): Y
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: AR-2652 CL
• Device Catalogue Number: 92-2002
• Device Lot Number: 381610
• Was Device Available for Evaluation?: Yes
• 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): Hospitalization
• Patient Age: 45 YR
• Patient Weight: 90