MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED EV 4.8 C - 13 MM; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 25275

Device Problem Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.

Event Description

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

Manufacturer Narrative

Device received for this event is being corrected from impl.Pick-up design ev 4.8 catalog #: 25526 to osseospeed ev 4.8 c - 13 mm catalog#: 25275.Correcting udi# from (b)(4).Correcting lot# from 130676 to unk.This is a follow up report for this corrected information.

• Brand Name: OSSEOSPEED EV 4.8 C - 13 MM
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18316975
• MDR Text Key: 330329939
• Report Number: 3013111692-2023-63881
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 07392532132827
• UDI-Public: 07392532132827
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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: 25275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/06/2023
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention