MAUDE Adverse Event Report: ZIMVIE US CORP LLC ABUT GOLD FRICTION-FIT 4. 5MM IMP; DENTAL ABUTMENT

Catalog Number	HLA4G
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the abutment screw was fractured.Implant placed to area #19.Post op visits (b)(6) 2017 & (b)(6) 2018 healing within normal limits.As such the implant was restored.Patient returned (b)(6) 2026 complaining of loose crown.Upon inspection the internal screw was broken.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided g4: additional pma/510(k) number k013227,k953101.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) hla4g, (abut gold friction-fit 4.5mm imp) for evaluation.Visual evaluation was performed, a fracture abutment has been identified inside the implant.Dhr review was completed for the subject lot number 63883395.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 63883395 for similar events and no other complaint was identified.The customer did not submit images for the reported event.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 fracture abutment has been identified inside the implant.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.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H11: added manufacturer narrative.

• Brand Name: ABUT GOLD FRICTION-FIT 4. 5MM IMP
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24468971
• Report Number: 0001038806-2026-01054
• Device Sequence Number: 18719213
• Product Code: DZE
• UDI-Device Identifier: 00889024015234
• UDI-Public: (01)00889024015234(17)450514(10)63883395
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011028
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: Other
• Device Catalogue Number: HLA4G
• Device Lot Number: 63883395
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2017
• 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
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic