MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 24285

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2023

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.

• Brand Name: TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM
• Type of Device: ABUTMENT, 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: 18491575
• MDR Text Key: 332641638
• Report Number: 3013111692-2024-00682
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 07392532067518
• UDI-Public: 07392532067518
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101005
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 24285
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/10/2024
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: IMPLANT 24942.
• Patient Outcome(s): Required Intervention