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

Catalog Number 25274

Device Problems Crack (1135); Fracture (1260); Difficult to Insert (1316); Mechanical Problem (1384); Migration or Expulsion of Device (1395); 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); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Abscess (1690); Erosion (1750); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Swelling (2091); Tissue Damage (2104); Sinus Perforation (2277); Discomfort (2330); Osteolysis (2377)

Event Type  malfunction  

Manufacturer Narrative

This report summarizes 1362 malfunction events.301 events were due to loss of osseointegration (b)(4).38 events involved fracture of the device or a component (b)(4).1007 events were due to the device failing to osseointegrate (b)(4).17 events involved cracking of the device or a component (b)(4).3 event was due to material deformation (b)(4).1 event was due to a device handling problem (b)(4).3 events were due to difficulties inserting the device or component (b)(4).1 event was due to migration or explusion of the device (b)(4).8 events were due to improper procedure or method (b)(4).2 events were due to a separation failure (b)(4).1 of which was a mount component (b)(4).1 of which was a screw component (b)(4).3 events were due to malposition of the device (b)(4).5 events were due to a mechanical issue (b)(4).1 event received where no known device or use problem was reported (b)(4).In 1016 events, there was no device problem found during evaluation.In 37 events, a fracture of a device or device component was found during evaluation.In 48 events, a stress problem was identified during evaluation.In 298 events, no result was available because no evaluation could be performed.In 6 events, a material deformation problem was found during evaluation.In 2 events, a friction problem was found during evaluation.In 12 events, an operational problem was identified during evaluation.In 1361 events, these are known inherent risks of the procedure.In 1 event, no device problem was found.In 227 events, the device failure was found to be related to the patient's condition.In 7 events, the clinicians failed to follow instructions.In 9 events, the cause was traced to off-label use.In 5 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 1362 malfunction events.This report summarizes 1362 malfunction events in 2q 2020 where patients' experienced endosseous dental implant failure.Of these events there were: 325 events where infection occurred.114 events where patients' experienced osteolysis.172 events where inflammation occurred.115 events where erosion occurred.2 events where patients experienced discomfort.6 events where swelling occurred.25 events where patients experienced pain.2 events where tissue damage occurred.1 event where a patient's sinus was perforated.3 events where abscess occurred.2 events where necrosis occurred.1 event where a patient experienced a fistula.

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: OSSEOSPEED EV 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: 10351487
• MDR Text Key: 233021622
• Report Number: 9612468-2020-00071
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K120414
• 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: 25274
• 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