MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. MULTI UNIT ABUTMENT 3MM, INT. HEX., SP; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	MA-S3480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dentsply sirona became aware of a malfunction for same/similar devices that could have possibly caused or contributed to a serious injury.Products return is requested and they 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 that upon arrival for prosthesis maintenance, both straight abutments fractured, leaving part of the abutment inside the implant.

• Brand Name: MULTI UNIT ABUTMENT 3MM, INT. HEX., SP
• Common Device Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): MIS IMPLANTS TECHNOLOGIES LTD.; p.o. box 7; bar lev industrial park 20156 00; IS 2015600
• Manufacturer (Section G): MIS IMPLANTS TECHNOLOGIES LTD.; p.o. box 7; bar lev industrial park 20156 00; IS 2015600
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24941124
• Report Number: 3004203816-2026-10552
• Device Sequence Number: 18374318
• Product Code: NHA
• UDI-Device Identifier: 07290108998917
• UDI-Public: 07290108998917
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K180282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MA-S3480
• Device Lot Number: W23016456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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