MAUDE Adverse Event Report: DENTSPLY IH INC. S ATLANTIS ABUTM GOLDSHADED TI; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	35503
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Screw broke.Ankylos implant may need to be trephined out.Doctor has ordered trephine drill to remove implant.It was reported that a patient experienced a dental implant loss.
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.

• Brand Name: S ATLANTIS ABUTM GOLDSHADED TI
• Common Device Name: ABUTMENT, 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: 19613674
• Report Number: 1222802-2024-00008
• Device Sequence Number: 12311404
• Product Code: NHA
• UDI-Device Identifier: 07392532083440
• UDI-Public: 07392532083440
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: MULTIPLE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 35503
• Device Lot Number: 1156024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ANKYLOS IMPLANT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown