MAUDE Adverse Event Report: DENTSPLY IH INC. ATLANTIS IO FLO IO-H-02; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
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.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
Customer reported implant loss.(b)(4).

• Brand Name: ATLANTIS IO FLO IO-H-02
• Common Device Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IH INC.; 590 lincoln street; north waltham MA 02451
• Manufacturer (Section G): DENTSPLY IH INC.; 590 lincoln street; north waltham MA 02451
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24248417
• Report Number: 1222802-2026-00004
• Device Sequence Number: 9658035
• Product Code: NDP
• UDI-Device Identifier: 07392532160646
• UDI-Public: 07392532160646
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 35229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT PROVIDED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown