MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 5.0 MM 10 MM; DENTAL IMPLANT

Catalog Number	1994
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number k962106.
Event or Problem Description
It was reported that there was an empty package.There was not implant.Procedure was completed using another implant or another device, new implant placed.
Additional Manufacturer Narrative
Zimvie received the packaging for one (1) 1994, (impl twist mp-1 5.0 mm 10 mm) for evaluation a visual evaluation was performed, the implant and flip top vial were not returned.The implants box packaging was returned empty.The coob is non-verifiable as the conditions of the product / packaging when delivered to the customer are unknown.Dhr review was completed for the subject lot number 2023010448.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 2023010448 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: packaging: other.¿ the customer did submit images for the reported event.The image was of a an empty box and plastic package.Based on the investigation and risk management file review, the most likely root cause determined was improper handling of product outside of zimvie controls.Therefore, based on the available information, a packaging malfunction could not be verified.The implants packaging was empty.The reported event/coob is non-verifiable since the condition of the product/packaging received by the customer was unknown.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, 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 5.0 MM 10 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: 20522334
• Report Number: 0002023141-2024-03387
• Device Sequence Number: 9105010
• Product Code: DZE
• UDI-Device Identifier: 00889024013179
• UDI-Public: (01)00889024013179(17)280309(10)2023010448
• 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
• 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): 03/03/2025

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: Health Professional
• Device Catalogue Number: 1994
• Device Lot Number: 2023010448
• 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: 10/24/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic