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

Catalog Number 32262433

Device Problems Positioning Failure (1158); Fracture (1260); Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017); Loss of Osseointegration (2408); Separation Failure (2547); Malposition of Device (2616); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Osteolysis (2377); Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  malfunction  

Manufacturer Narrative

This report summarizes 1290 malfunction events.256 events were due to loss of osseointegration.52 event involved fracture of the device or a component.974 events were due to the device failing to osseointegrate.1 event was reported without identified device or use problem.4 events were due to a separation failure of the mount component.Of which, 2 events included separation of a screw component.1 event there was a detachment of mount device component.2 events were due to malposition of the device.1 event was due to a positioning failure.1 event was due to improper or incorrect procedure or method.In 490 events, there was no device problem found during evaluation.In 45 events, a fracture of a device or device component was found during evaluation.In 63 events, a stress problem was identified during evaluation.In 749 events, no result was available because no evaluation could be performed.In 2 events, a friction problem was identified during evaluation.In 7 events, an operational problem was identified during evaluation.In 1288 events, these are known inherent risks of the procedure.In 198 events, the device failure was found to be related to the patient's condition.In 2 events, a user error caused or contributed to the event.In 2 events, the cause cannot be traced to the device.In 1 event, a clinician failed to follow instructions.In 1 event, the cause was traced to transport/storage.In 3 events, the cause was traced to off-label use.

Event Description

This report summarizes 1290 malfunction events.This report summarizes 1290 malfunction events in 2q 2020 where patients' experienced endosseous dental implant failure.Of these events there were: 268 events where infection occurred.425 events where patients experienced osteolysis.108 events where inflammation occurred.216 events where erosion occurred.1 event where a patients nerve proximity not otherwise specified.9 events where patients experienced pain.1 event where swelling 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, vastra gotalands lan [se-14] S-431 21; SW S-431 21
• MDR Report Key: 10347250
• MDR Text Key: 234202236
• Report Number: 9612468-2020-00064
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K073075
• 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: 32262433
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2021
• Patient Sequence Number: 1