MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL ABUTMENT

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2023

Event Type  Injury  

Event Description

It was reported that the implant abutment alongside the restoration was separated from the implant and an abutment fracture was discovered.X-rays also confirmed that a piece of abutment was fractured inside the implant.The implant was removed.Tooth site #26.

Manufacturer Narrative

Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.D1: brand name is not provided / unknown.D4: catalog number and lot number are not provided / unknown.D10: tsv4b10, imp,tsv,4.1mm,sbm,10, lot number 63847812.E1: initial reporter¿s title is not provided / unknown.

Event Description

No additional or corrected information to report.

Manufacturer Narrative

This report is being submitted to report additional information.Follow up with customer confirmed item and lot number.G4: additional 510(k) numbers are k013227 and k953101.

• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18957760
• MDR Text Key: 338303669
• Report Number: 0002023141-2024-00891
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT, SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic