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

Catalog Number 32262442

Device Problems Crack (1135); 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); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Erosion (1750); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Sinus Perforation (2277); Osteolysis (2377); Numbness (2415)

Event Type  malfunction  

Manufacturer Narrative

This report summarizes 1071 malfunction events.308 events were due to loss of osseointegration (b)(4).663 events were due to the device failing to osseointegrate (b)(4).87 events involved fracture of the device or a component (b)(4).1 event involved an improper or incorrect procedure or method (b)(4).9 events, there were issues reported with a screw component (b)(4).10 events involved a failure to separate of a device or a component (b)(4).1 event was due to material deformation (b)(4).2 events, there was no known device problem reported (b)(4).2 events, the device was malpositioned (b)(4).In 1 event, a positioning failure was reported (b)(4).9 events, there were issues reported with a mount component (b)(4).In 1 event there was a mechanical problem identified (b)(4).In 2 events, it was reported that a device or a device component was cracked (b)(4).In 956 events, there was no device problem found during evaluation (b)(4).In 85 events, a fracture of a device or device component was found during evaluation (b)(4).In 99 events, a stress problem was identified during evaluation (b)(4).In 12 events, an operational problem was identified (b)(4).In 1 event, a deformation problem was found during evaluation (b)(4).In 18 events, there are no findings available because the device was not returned for evaluation (b)(4).In 3 events, a friction problem was identified (b)(4).In 1 event, an environment problem was identified (b)(4).In 1070 events, these are known inherent risk of the procedure.Furthermore, in 256 events, the device failure was found to be related to the patient's condition.1 event was a result of the clinician failure to follow instructions.3 events were a result of user error.

Event Description

This report summarizes 1071 malfunction events.This report summarizes 1071 malfunction events where patients' experienced endosseous dental implant failure.Of these events there were: 205 events where inflammation occurred.210 events where infection occurred.93 events where patients' experienced osteolysis.70 events where erosion occurred.4 events where patients' experienced pain.1 event where numbness occurred.1 event where a patients' experienced sinus perforation.1 event where patients' experienced fistula.3 events where abscess 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: 9656524
• MDR Text Key: 189501287
• Report Number: 9612468-2020-00011
• 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: 32262442
• 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