MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) PRIMETAPER EV Ø4.8 X 9MM OS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 68011105

Device Problems Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 07/13/2023

Event Type  Injury  

Event Description

It was reported that a patient experienced a dental implant loss.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.

Manufacturer Narrative

Fda coding was missed in the initial report.Adding additional medical device problem code 2017.This is a follow up report to add this additional code.Fda coding was missed in the initial report.Adding additional type of investigation 10.This is a follow up report to add this additional code.Fda coding was missed in the initial report.Adding additional investigation conclusions 18.This is a follow up report to add this additional code.Correcting udi # from (b)(4).Device received for this event is being corrected from primetaper ev ø4.2 x 9mm os catalog # 68011098 to primetaper ev ø4.8 x 9mm os catalog # 68011105.This is to correct and remove the codes that were initially reported - removing codes for: investigation findings code - 3221.The correct codes for this complaint are: investigation findings code - 213.This is a follow up report for theses corrections.

• Brand Name: PRIMETAPER EV Ø4.8 X 9MM OS
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17556041
• MDR Text Key: 321235208
• Report Number: 9612468-2023-08150
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07392532276781
• UDI-Public: 07392532276781
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 68011105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/04/2023
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 25302
• Patient Outcome(s): Required Intervention