MAUDE Adverse Event Report: ZIMMER DENTAL EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH

Model Number	CM318
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inner vial was deteriorated, in bad condition and implant was bit placed.Procedure was completed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One implant was returned for investigation.Visual evaluation of the as returned product identified no damage or signs of malfunction that would contribute to the event.Measurements match drawing.(b)(6) (due: (b)(6), 2022) functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was low bone density (type iv).The reported device was intended for tooth # 12 (fdi) and was not used.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: instructions for use for implants, abutments and restorative components for 3.1mmd eztetic¿ implant ifu 9228 rev.1 ¿ 11/19.Information identified: 'contraindications' 'warnings' 'precautions' 'adverse effects'.Dhr review: dhr review was completed for the subject lot number (1240108).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: complaint history review was performed for the reported lot number (1240108) for similar events and no other complaint was identified.Review completed utilizing keywords: 'damaged or un-sealed sterile barrier' post market trend review: august post market trending was reviewed and there were no actionable events or corrective actions for the reported event (damaged or un-sealed sterile barrier) or product (cm318).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH
• 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: 14447286
• Report Number: 0002023141-2022-01230
• Device Sequence Number: 4576789
• Product Code: DZE
• UDI-Device Identifier: 00889024343627
• UDI-Public: (01)00889024343627(17)251008(10)1240108
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 10/08/2025
• Device Model Number: CM318
• Device Catalogue Number: CM318
• Device Lot Number: 1240108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2020
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Male