MAUDE Adverse Event Report: ZIMMER DENTAL 15 DEG TAPER,3.5P 2MM-3MM; DENTAL ABUTMENT

Catalog Number	15AT323
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported two abutments fractured.Patient came to the clinic with screws in hand.Abutments were placed on (b)(6) 2016 and removed on (b)(6) 2025.The process was completed with other abutments, tooth location 12 and 22.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.D10: concomitant medical product: catalog # 15at323, 15 deg taper, 3.5p 2mm-3mm, lot: 63463097.Zimvie received one (1) 15at323, (15 deg taper,3.5p 2mm-3mm) for evaluation.Visual evaluation was performed.Hex of the abutment was found fractured.Dhr review was completed for the subject lot number 63463097.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 63463097 for similar events and one other complaint was identified.Review completed utilizing keywords: dental: functional: fracture: abutment.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The abutment hex was found fractured.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: 15 DEG TAPER,3.5P 2MM-3MM
• Common Device Name: 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: 23063065
• Report Number: 0002023141-2025-02529
• Device Sequence Number: 21252897
• Product Code: NHA
• UDI-Device Identifier: 00889024012042
• UDI-Public: (01)00889024012042(10)63463097(17)210831
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111853
• Exemption Number: 5645646
• 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): 09/16/2025

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: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 15AT323
• Device Lot Number: 63463097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT SEE H10 NARRATIVE
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic