MAUDE Adverse Event Report: HENRY SCHEIN HENRY SCHEIN; IMPLANT, DENTAL

Catalog Number 900-1887

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2017

Event Type  Injury  

Event Description

Needle broke and was lodged in the patient gum tissue.

• Brand Name: HENRY SCHEIN
• Type of Device: IMPLANT, DENTAL
• Manufacturer (Section D): HENRY SCHEIN; melville NY 11747
• MDR Report Key: 7203000
• MDR Text Key: 97712804
• Report Number: MW5074653
• Device Sequence Number: 1
• Product Code: NHA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900-1887
• Device Lot Number: F06309AA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2018
• 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): Required Intervention
• Patient Age: 38 YR