MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH TIDESIGN 4.5/5.0 -Ø5.5,1.5 MM; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	24235
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient came in with crown loose, upon referral, the hex connection of the abutment has fractured, doctor manage to retrieve the remaining fractured complaint.It was reported that a patient experienced a dental implant loss.
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.
Additional Manufacturer Narrative
Correcting this event from reportable to non-reportable after receiving additional information.Information received that the implant is not affected, it can be loaded again, so case is not serious as first classified.Please disregard the initial report.

• Brand Name: TIDESIGN 4.5/5.0 -Ø5.5,1.5 MM
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18922435
• Report Number: 3013111692-2024-08157
• Device Sequence Number: 14985186
• Product Code: NHA
• UDI-Device Identifier: 07392532062797
• UDI-Public: 07392532062797
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K101005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: 24235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/14/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/03/2024
• 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: OSSEOSPEED TX 4.5 - 9 - 24951 - LOT: 172879COVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown