MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ASTRATECH IMPL EV 4.2C 15MM OS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number	26335
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.The device was not evaluated because the issue is a known inherent risk of the device.Since in this case a guide was used we will investigate the guide planning, even though it is not very likely that the insufficient osseointegration is linked to an issue with the guide.However, in case any new or additional information will be gained from this investigation a follow-up report will be sent.We will continue to track and monitor the trend this mdr submission is a late submission.A capa has been issued.

• Brand Name: ASTRATECH IMPL EV 4.2C 15MM OS
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• 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: 17316301
• Report Number: 3013111692-2023-48889
• Device Sequence Number: 6226268
• Product Code: DZE
• UDI-Device Identifier: 07392532214363
• UDI-Public: 07392532214363
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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 Model Number: 26335
• Device Catalogue Number: 26335
• Device Lot Number: 483800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATLANTIS CASE 0014029349, ABUTMENT & HEALING ABUTM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown