MAUDE Adverse Event Report: ZimVie US Corp LLC IMPL TWIST MP-1 3.75 MM 1 0 MM; Dental Implant

Catalog Number	1989
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor had followed the surgical procedures to place the implant in 1989 at tooth site 15.Three weeks after the procedure, the patient developed an infection.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) b3: date of event unknown / not provided d9: device availability unknown / not provided g4: premarket identification k943604 a summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.

• Brand Name: IMPL TWIST MP-1 3.75 MM 1 0 MM
• 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: 50751413
• Report Number: 0001038806-2026-04756
• Device Sequence Number: 10235850
• Product Code: DZE
• UDI-Device Identifier: 00889024013124
• UDI-Public: (01)00889024013124(17)280519(10)2023031207
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K013494
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/14/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1989
• Device Lot Number: 2023031207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2023
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 143 LB