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

Catalog Number 32262423

Device Problems Fracture (1260); Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017); Loss of Osseointegration (2408)

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

Event Type  malfunction  

Manufacturer Narrative

This report summarizes 46 malfunction events.10 events were due to loss of osseointegration ((b)(4)).35 events were due to the device failing to osseointegrate ((b)(4)).3 events involved an improper or incorrect procedure or method ((b)(4)).1 events involved fracture of the device or a component ((b)(4)), which was a screw component ((b)(4)).In 45 events, there was no device problem found during evaluation.In 1 event, a fracture of a device or device component was found during evaluation.In 34 events, these are known inherent risk of the procedure.Furthermore, it was found in 3 events that the clinician failed to follow instructions and used the product off-label or contraindicated use.In 11 events, the device failure was found to be related to the patient's condition.

Event Description

This report summarizes 46 malfunction events.This report summarizes 46 malfunction events in 4q 2019 where patients' experienced endosseous dental implant failure.Of these events there were: 10 events where infection occurred.8 events where patients' experienced osteolysis.6 events where inflammation occurred.10 events where erosion occurred.

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: XIVE S PLUS IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, S-431 21; SW S-431 21
• MDR Report Key: 9656528
• MDR Text Key: 191867161
• Report Number: 9612468-2020-00001
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K032750
• 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: 32262423
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2021
• Patient Sequence Number: 1