MAUDE Adverse Event Report: ZimVie US Corp LLC FULL OSSEOTITE® IMPLANT 4 X 10MM; Dental Implant

Catalog Number	FOS410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.
Event or Problem Description
The doctor reports that the dental implant failed because it fractured by the body.Only the upper portion of the implant, including the implant head, was returned.The fractured fragment of the implant body was not returned.The doctor reports that the procedure was not concluded by placing another implant.Tooth site 27.Bone type: ii.

• Brand Name: FULL OSSEOTITE® IMPLANT 4 X 10MM
• Common Device Name: Dental Implant
• 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 ; +1(561)971-3230
• MDR Report Key: 50053827
• Report Number: 0001038806-2026-03967
• Device Sequence Number: 18787898
• Product Code: DZE
• UDI-Device Identifier: 00844868003601
• UDI-Public: (01)00844868003601(17)241219(10)2019120852
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• 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): 07/28/2026

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: Lay User/Patient
• Device Expiration Date: 12/19/2024
• Device Catalogue Number: FOS410
• Device Lot Number: 2019120852
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female