MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) ANKYLOS C/X IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 31010425

Device Problems Crack (1135); Fracture (1260); Difficult to Insert (1316); Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017); Loss of Osseointegration (2408); Separation Failure (2547); Malposition of Device (2616); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems Erosion (1750); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteolysis (2377); Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  malfunction  

Manufacturer Narrative

This report summarizes 1505 malfunction events.375 events were due to loss of osseointegration.(b)(4).142 events involved fracture of the device or a component.(b)(4).963 events were due to the device failing to osseointegrate.(b)(4).3 events involved cracking of the device or a component.(b)(4).1 event was due to material deformation.(b)(4).1 event was due to material twisted or bent.(b)(4).3 events were due to difficulties inserting the device or component.(b)(4).1 event was due to improper procedure or method.(b)(4).18 events were due to a separation failure.(b)(4).3 events were due to malposition of the device.(b)(4).28 events were due to an issue with a mount component.(b)(4).22 events were due to an issue with a screw component.(b)(4).In 715 events, there was no device problem found during evaluation.In 121 events, a fracture of a device or device component was found during evaluation.In 124 events, a stress problem was identified during evaluation.In 653 events, no result was available because no evaluation could be performed.In 11 events, a friction problem was found during evaluation.In 37 events, an operational problem was identified during evaluation.In 1505 events, these are known inherent risks of the procedure.In 1 event, no device problem was found.In 237 events, the device failure was found to be related to the patient's condition.In 2 events, the clinicians failed to follow instructions.In 1 event, the cause was traced to off-label use.In 2 events, the cause was traced to unintended user error.In 3 events, the cause could not be traced to the device.

Event Description

This report summarizes 1505 malfunction events.This report summarizes 1505 malfunction events in 2q 2020 where patients' experienced endosseous dental implant failure.Of these events there were: 309 events where infection occurred.157 events where patients' experienced osteolysis.237 events where inflammation occurred.163 events where erosion occurred.5 events where patients experienced pain.1 event where a fistula occurred.1 event where a patient's nerve proximity was not otherwise specified.

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: ANKYLOS C/X 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: 10351505
• MDR Text Key: 233023055
• Report Number: 9612468-2020-00073
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K140347
• 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: 31010425
• 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