MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) FIXTURE OSSEOSPEED IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 24511

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Loss of Osseointegration (2408)

Patient Problems Erosion (1750); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteolysis (2377)

Event Type  malfunction  

Manufacturer Narrative

This report summarizes 29 malfunction events.24 events were due to loss of osseointegration (device problem code: (b)(4)).5 events involved fracture of the device or a component (device problem code: (b)(4)).1 event was due to improper or incorrect procedure or method (device problem code: (b)(4)).In 22 events, there was no device problem found during evaluation (evaluation results code: 213).In 5 events, a fracture of a device or device component was found during evaluation (evaluation results code: 3252).In 5 events, a stress problem was identified during evaluation (evaluation results code: 3243).In 2 events, no result was available because no evaluation could be performed (evaluation results code: 3221).In all 29 events, these are known inherent risks of the procedure.In 4 events, the device failure was found to be related to the patient's condition.In 1 event, the cause was traced to off-label use / failure ot follow instructions.

Event Description

This report summarizes 29 malfunction events.This report summarizes 29 malfunction events in 2q 2020 where patients' experienced endosseous dental implant failure.Of these events there were: 3 events where infection occurred.1 events where patients' experienced osteolysis.7 events where inflammation occurred.8 events where erosion occurred.1 events where patients experienced pain.

Manufacturer Narrative

Upon further discussion with fda, the events initially reported in this summary report are not considered malfunction events, and are serious injury events.Therefore, individual reports have been submitted for the events previously summarized in this report.This summary report now reflects zero events and can be disregarded/deleted/removed.

• Brand Name: FIXTURE OSSEOSPEED IMPLANT
• 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
• MDR Report Key: 10351481
• MDR Text Key: 234615833
• Report Number: 9612468-2020-00067
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K024111
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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: No Information
• Device Catalogue Number: 24511
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2021
• Patient Sequence Number: 1