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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Additional information received that this case was erroneously categorised as serious.The classification was changed to fracture of abutment non-serious, not reportable.This is a follow up report for this additional information.This follow up report is to correct this event to a non-reportable.Please disregard the initial report.This is a follow up report for this correction.

• Brand Name: TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM
• Common Device Name: 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20224096
• Report Number: 3013111692-2024-28161
• Device Sequence Number: 7327785
• Product Code: NHA
• UDI-Device Identifier: 07392532067518
• UDI-Public: 07392532067518
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 24285
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANT ASTRA TX 3,5/4,0 SLEEPER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown