MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH FRI COVER SCREW FOR IMPLD 3.8; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	45-1140
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/18/2023
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
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.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code - 1260.Component code 568 removing this code.Investigation findings code - 3252 and 3243.The correct codes for this complaint are: medical device problem code - 2547; investigation findings code - 3253; this is a follow up report to correct this code.

• Brand Name: FRI COVER SCREW FOR IMPLD 3.8
• 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: 19948769
• Report Number: 3013111692-2024-24317
• Device Sequence Number: 15353927
• Product Code: DZE
• UDI-Device Identifier: 07392532226953
• UDI-Public: 07392532226953
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K945847
• 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,Followup
• Report Date (Section B): 10/10/2024

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: 45-1140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/10/2024
• 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: 1 IMPLANT XIVE S PLUS IMPL D3.8/L9.5, REF: 322624.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown