MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ASTRATECH IMPL EV 3.6S 17MM OS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	26316
Medical Device Problem Codes	Failure to Osseointegrate (1863); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.No information besides implant failure was received so far.Additional information and product return is requested.Follow-up report will be sent in case additional information will be received.Trend is tracked and monitored.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Adding udi#: (b)(4).Adding implanted date: on (b)(6) 2023.Adding explanted date: on (b)(6) 2023.This is a follow up report for this additional information.Fda coding was missed in the initial report.Adding additional investigation conclusions code 50.This is a follow up report to add this additional code.Device received for this event is being corrected from unknown atis implant catalog# unknown atis implant to astratech impl ev 3.6s 17mm os catalog#: 26316.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code -4580.Medical device problem code - 3190.The correct codes for this complaint are: health effect - clinical code -2377.Medical device problem code - 1863.This is a follow up report for this corrected information.

• Brand Name: ASTRATECH IMPL EV 3.6S 17MM 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: 18444228
• Report Number: 3013111692-2024-65776
• Device Sequence Number: 18178998
• Product Code: DZE
• UDI-Device Identifier: 07392532214233
• UDI-Public: 07392532214233
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: 26316
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 01/23/2024
• 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