MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.7MM MTX FULL, 10; DENTAL IMPLANT

Model Number	TMTWB10
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer went to open an implant package for a case and the vial was empty.Was discovered when the assistant went to open the implant for placement.When they opened the vial, there was no implant inside.We did have other implants in stock so we were able to complete the procedure.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.K113753, k112160.
Additional Manufacturer Narrative
An imp tm 4.7mm mtx full, 10 (tmtwb10) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.Vial was returned and seal has been broken and opened.No products inside.Pictures were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1240272).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1240272) for similar event and no other complaint was identified.Nov post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.H3 other text : device not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP TM 4.7MM MTX FULL, 10
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15210112
• Report Number: 0002023141-2022-02028
• Device Sequence Number: 2199361
• Product Code: DZE
• UDI-Device Identifier: 00889024019034
• UDI-Public: (01)00889024019034(17)251005(10)1240272
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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 Expiration Date: 10/05/2025
• Device Model Number: TMTWB10
• Device Catalogue Number: TMTWB10
• Device Lot Number: 1240272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 01/08/2023
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2020
• 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