MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) OSSEOSPEED TX 5.0S - 9 MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 24971

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Failure of Implant (1924); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Nerve problems are a well-known complication during implant surgery in the posterior region of the mandible.In this case there is nothing that indicate that the nerve problems are related to the astra tech product.It is rather a surgery related complication.This event is reportable per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

According to the available information a (b)(6) year-old female patient received one osseospeed tx 5.0s - 9 dental implant, in position 30 (fdi 46) on (b)(6) 2021.The implant was too long for its position and interfered with the nerve and caused numbness.The implant was removed on (b)(6) 2021.After the removal of the implant the patient's numbness was resolved and no further treatment was necessary.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: OSSEOSPEED TX 5.0S - 9 MM
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, vastra gotalands lan [se-14] S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, vastra gotalands lan [se-14] S-431 21; SW S-431 21
• Manufacturer Contact: joleta ness ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12340453
• MDR Text Key: 267209019
• Report Number: 9612468-2021-57998
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 24971
• Device Lot Number: 464736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention