MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH MULTIBASE AB EV (L) 1.5MM NI; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	68012210
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dentsply sirona became aware of a malfunction with insufficient information.It is unclear whether the malfunction could have possibly caused or contributed to a serious injury.Product return and additional information is requested and will be evaluated after receipt.In case any new or additional information will be gained a follow-up report will be sent.Trend is tracked and monitored.
Event or Problem Description
It was reported by the customer that there was a prosthetic issue.Additional information was requested, but not received.

• Brand Name: MULTIBASE AB EV (L) 1.5MM NI
• Common Device Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• 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: 24964749
• Report Number: 3013111692-2026-13975
• Device Sequence Number: 10496057
• Product Code: NHA
• UDI-Device Identifier: 07392532278778
• UDI-Public: 07392532278778
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 68012210
• Device Lot Number: 534616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/23/2026
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT PROVIDED
• Patient Sex: Unknown