MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ASTRATECH IMPL EV 4.8PC 13MMOS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	26414
Medical Device Problem Codes	Off-Label Use (1494); Loss of Osseointegration (2408); Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received for this event: patient had implant restored out of country and wrong abutment was used.The abutment ruined the internal components of implant and a correct abutment could no longer be seated.Abutment was "3rd-party" so assumably not a ds product.This is a follow up report for this additional information that was received.Additional fda coding being added after investigation of device.Adding additional health effect impact code 4627.This is a follow up report to add this additional code.Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.Additional fda coding being added after investigation of device.Adding additional investigation conclusions 24.This is a follow up report to add this additional code.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code - 2408 investigation findings code - 3221 the correct codes for this complaint are: medical device problem code - 2976 and 1494 investigation findings code - 3211 and 4248 investigation conclusions code ¿ 24 this is a follow up report for these corrected codes.
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.We will continue to track and monitor the trend.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.

• Brand Name: ASTRATECH IMPL EV 4.8PC 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19674661
• Report Number: 3013111692-2024-19910
• Device Sequence Number: 7479862
• Product Code: DZE
• UDI-Device Identifier: 07392532235955
• UDI-Public: 07392532235955
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 26414
• Device Lot Number: 461392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 07/26/2024
• 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