MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 3.7, 10,MTX,MC,MG,HA; DENTAL IMPLANT

Model Number	TSVMH10
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the sterile packaging was missing the implant.The doctor confirmed that the surgery was completed with another implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One imp, tsv, 3.7, 10,mtx,mc,mg,ha (tsvmh10) was returned for investigation.Visual inspection of the as returned product identified that the vial is empty of the components.The vial cap is noted to already be opened.Device history record (dhr) review was completed for the subject lot number 1224544.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 (1224544) for similar event using keyword incorrect component quantity and no other complaint was identified.Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.As the packaging was already opened, the circumstances of device delivery could not be recreated.

• Brand Name: IMP, TSV, 3.7, 10,MTX,MC,MG,HA
• 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: 12165287
• Report Number: 0002023141-2021-01787
• Device Sequence Number: 11759509
• Product Code: DZE
• UDI-Device Identifier: 00889024344099
• UDI-Public: (01)00889024344099(17)240619(10)1224544
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 06/19/2024
• Device Model Number: TSVMH10
• Device Catalogue Number: TSVMH10
• Device Lot Number: 1224544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• 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: 06/21/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female