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  

Manufacturer Narrative

On (b)(6) 2021 (b)(6) usa, llc received a written summons which contained the following information: on (b)(6) 2018 patient had dental implant surgery in the area of 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 in the documentation it 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 ultimately lost part of his lung.No further information regarding patients' follow-up surgery is provided.Article and lot number of the involved "foreign body" are not reported in the documentation.The part in question is not available to (b)(6) for investigation and due to the legal nature, it can only be requested via the involved legal representations.It is not possible to confirm a (b)(6) article and lot number and its¿ condition.While the (b)(6) article and lot number cannot be confirmed, based on the information provided we estimate that an adapter tap for handpiece could be involved.Based on the dentist name and address provided in the summons, (b)(6) customer #(b)(6) is involved.(b)(6) registered this case under complaint number #1500192751.The sales history review for customer #(b)(6) shows the customer bought various adapter taps for blt implants together with the corresponding implants during the period (b)(6) 2017 ¿ (b)(6) 2018.Based on this we have registered this case representatively under article 026.0010 blt tap diameter 4.1mm lot nk247.(b)(6) investigation covered the following: review batch production record review of 10x blt tap, ø4.1, l25mm, sst/tan bought by customer #1500192751 in the period july 2017 ¿ october 2018.Review of all dhr (device history records) indicates that all manufacturing, inspection and release activities met the requirements of the dmr.Review risk management.Risk review confirmed that risk of asphyxiation is assessed, mitigations are in place and risk is reduced as far as possible.Review ifu and user documentation.The adapter tap is a multi-use surgical instrument which is provided non-sterile.It¿s use is limited to 10 times.It has to be sterilized and checked for functionality by the user prior to use.It is an unguided cutting instrument that is used for osteotomy preparation before implant placement.It is inserted into the handpiece adapter before use.Review of the ifu 701124 valid in 2018 confirms that it includes the note that the part has to be carefully checked for proper function and damages before every use.Further the care and maintenance 2018, includes instructions on inspection, maintenance, functional test and packaging specifically indicating that the instruments must be subjected to functional testing.Review dhf and v<(>&<)>v for blt taps and handpiece adapter concluded that retention is a design requirement which passed validation testing and verification.Review of changes for both the adapter tap and handpiece adapter confirmed that there were no changes which could have an impact on the functionality regarding retention between the two parts.In conclusion, the review of all of the above has not identified any anomalies and complaint cannot be confirmed.No corrective actions are considered required at this time.

Event Description

On (b)(6) 2021 (b)(6) 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 in the documentation it 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 ultimately 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
• Manufacturer (Section G): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 11812845
• MDR Text Key: 254648163
• Report Number: 0009613348-2021-32690
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 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
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention