MAUDE Adverse Event Report: META DENTAL CORP. METAPASTE; RESIN, ROOT CANAL FILLING

Device Problems Improper or Incorrect Procedure or Method (2017); Overfill (2404)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 10/24/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, endodontist overfilled root canal of tooth number 30 resulting in anesthesia and dysesthesia of my right inferior alveolar nerve.On (b)(6) 2018, oral surgeon removed metapaste overfill and neuroma.Grafting done for inferior alveolar nerve repair with very guarded prognosis.Anesthesia is likely permanent.Neuropathic pain improved post nerve repair surgery.Anesthesia and dysesthesia secondary to tooth number 30 root canal overfilled of metapaste into the inferior alveolar nerve.Date the person first started using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018; did the problem stop after the person reduced the dose or stopped taking or using the product? no.

• Brand Name: METAPASTE
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): META DENTAL CORP.
• MDR Report Key: 8194409
• MDR Text Key: 131621085
• Report Number: MW5082543
• Device Sequence Number: 0
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 40 YR
• Patient Weight: 61