MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH COVER SCREW EV 4.2; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	25282
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
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.
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: device received for this event is being corrected from astratech impl ev 4.2s 9mm os catalog # 26322 to cover screw ev 4.2 catalog # 25282.Correcting: udi #: from udi# (b)(4) to udi # (b)(4).Lot # : from lot # 507527 to lot # unknown.Concomitant medical products from cover screw 26322-507527 to astratech impl ev 4.2s 9mm os.This is a follow up report to correct this information.

• Brand Name: COVER SCREW EV 4.2
• 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: 18893306
• Report Number: 3013111692-2024-07706
• Device Sequence Number: 7588946
• Product Code: DZE
• UDI-Device Identifier: 07392532133794
• UDI-Public: 07392532133794
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 25282
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/07/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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: ASTRATECH IMPL EV 4.2S 9MM OS; COVER SCREW 26322-507527
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown