MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BLT TAP, 4.1, L25MM, SST/TAN; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS - DENTAL IMPLANT ACCESORIES

Catalog Number 026.0010

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

Patient Problems Aspiration/Inhalation (1725); Foreign Body In Patient (2687)

Event Date 10/24/2018

Event Type  Injury  

Event Description

On april 14th, 2021 straumann usa, llc received a written summons which contained the following information: on (b)(6) 2018 patient had dental implant surgery in area upper tooth #8.During surgery dentist dropped a foreign body, which appears to have been the tap of the hand piece being used for the implant surgery.The foreign body was dropped down the patients throat and was aspirated where it lodged in the lower lobe of the patient's right lung.Patient had x-ray confirming metal tool in the patient's lung.Patient underwent surgery and had a lobectomy of that part of his lower right lobe which enveloped the foreign body.Further documentation states that the drill bit did not stay properly retained in the connector as it appears to be missing an o-ring or spring to keep it retained in the connector.Patient underwent multiple procedures and lost part of his lung.No further information regarding patients' follow-up surgery is provided.

• Brand Name: BLT TAP, 4.1, L25MM, SST/TAN
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS - DENTAL IMPLANT ACCESORIES
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 11812700
• MDR Text Key: 250216881
• Report Number: 0001222315-2021-07863
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/14/2021,05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 026.0010
• Device Lot Number: NK247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/12/2021
• Event Location: Other
• Date Report to Manufacturer: 04/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention