MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ASTRATECH IMPL EV 4.2PC 13MMOS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number	25455
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The implant was not evaluated, but the given information.Also the guide and planning will be evaluated.As per complainant the implant was removed due to issues with the guide.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
This follow up report is to correct information that was submitted in the initial mdr: correcting: udi #: from udi# (b)(4).Catalog #: from catalog # 25455 to catalog # 26384.Lot # : from lot # unknown to lot # 503072.This is a follow up report to correct this information.

• Brand Name: ASTRATECH IMPL EV 4.2PC 13MMOS
• 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: 17288403
• Report Number: 3013111692-2023-48480
• Device Sequence Number: 15025424
• Product Code: DZE
• UDI-Device Identifier: 07392532214684
• UDI-Public: 07392532214684
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130999
• 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): 07/25/2023

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: 25455
• Device Catalogue Number: 26384
• Device Lot Number: 503072
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/22/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown