MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. PROLARYN PLUS INJECTABLE IMPLANT; POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, caj sclerosis, was deemed to meet serious injury criteria of resulting in permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as the lot number was not reported.

Event Description

This spontaneous report was received from a (b)(6) surgeon and concerns a male patient.He was injected with radiesse voice (prolaryn+), for vocal cord palsy.As reported, at the time of the injection the patient's arytenoid muscle was functional.After the radiesse voice (prolaryn+) treatment, the patient experienced that the arytenoid muscle was not functioning.The outcome of the event was not reported.In the opinion of the reporter, the patient had a reaction to radiesse voice (prolaryn+).Follow-up information was received on 28-oct-2019: this case was upgraded to serious.The event arytenoid muscle was not functioning was amended to caj sclerosis and recoded from injection site muscle reaction to device dislocation.The reporter confirmed that, prior to the injection with radiesse voice (prolaryn+), the joint worked normally.The reporter found it difficult to determine whether or not it was the radiesse voice (prolaryn+) that caused the cricoarytenoid joint (caj) sclerosis, with hoarseness, strain, and breathiness as symptoms.According to the reporter, it was possible (but could not be proven until post mortem) that the injection tracked posteriorly and infiltrated the caj, stimulated an inflammatory reaction, and the resulting fibrosis caused stiffness and immobility of the joint.As corrective treatment, an external approach implant and possible arytenoid adduction suture were planned.In the opinion of the reporter, there was going to be a permanent damage of the arytenoid cartilage.

• Brand Name: PROLARYN PLUS INJECTABLE IMPLANT
• Type of Device: POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 9347167
• MDR Text Key: 167152465
• Report Number: 3013840437-2019-00019
• Device Sequence Number: 1
• Product Code: KHJ
• Combination Product (y/n): N
• PMA/PMN Number: K013243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Disability