MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 3.75 MM 1 1.5 MM; DENTAL IMPLANT

Catalog Number	2120
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gingival cuff won't fit.After placing the 2120 implant, three gingival cuffs were tried, but they only went in partway.When a different implant was substituted, the gingival cuff was able to be attached immediately.The doctor is requesting an investigation, as the internal thread of the implant may be defective.He is requesting an answer as to why the gingival cuff cannot be attached.The sales representative reported that the gingival cuff used was either 1806, 1807, 1808, or 1809.Procedure completed using another implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.
Additional Manufacturer Narrative
Zimvie received one (1) 2120, (impl twist mp-1 3.75 mmd 11.5 mml) for evaluation.Visual evaluation and functional test were performed.Returned implants shows some signs of wear/use.Some bone residue can be observed on its external threads.Some minor damage to its inner threads was identified but in-house screw threads with no issue.Tested with in-house abutment and it engages, disengages and seats as intended.Dhr review was completed for the subject lot number 2023021223.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 2023021223 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : fit : other¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-002z1 rev 9, the most likely root cause determined from the investigation was user error.Therefore, based on the available information, a device malfunction has not occurred.During functional testing the product functioned as intended, no problem found.The reported event was unconfirmed following functional testing and physical evaluation.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL TWIST MP-1 3.75 MM 1 1.5 MM
• Common Device Name: DENTAL IMPLANT
• 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: 21855409
• Report Number: 0002023141-2025-00993
• Device Sequence Number: 7841974
• Product Code: DZE
• UDI-Device Identifier: 00889024013261
• UDI-Public: (01)00889024013261(17)280428(10)2023021223
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013494
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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 Catalogue Number: 2120
• Device Lot Number: 2023021223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/17/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic