MAUDE Adverse Event Report: ZIMMER DENTAL 30 DEG TAPER 3.5P 3MM-5MM; DENTAL ABUTMENT

Model Number	30AT335
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that dr.Indicated fracture.4 implants were implanted on the upper jaw on (b)(6) 2021.The implant torque was 35n.The primary stability was good.The immediate loading was performed.1 year after temporary restoration, 1 30°tapered abutment was loose.The fracture of the connection part between abutment and implant was found.The implant was removed on the same day.Implant size: tsvtb13/ batch number 63791285.
Additional Manufacturer Narrative
A 30 deg taper 3.5p 3mm-5mm (30at335) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and fracture at the hex.Also, an associated product tsvtb13 has not been returned.However, this item is listed as associated item only and did not cause or contribute to the event.No further investigation will be conducted.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Pictures were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (63873017).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 (63873017) for similar event and no other complaint was identified.Jan 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 did occur, and the reported event was confirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 30 DEG TAPER 3.5P 3MM-5MM
• Common Device Name: DENTAL ABUTMENT
• 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: 15642162
• Report Number: 0002023141-2022-02652
• Device Sequence Number: 6377601
• Product Code: DZE
• UDI-Device Identifier: 00889024013575
• UDI-Public: (01)00889024013575(17)221130(10)63873017
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111853
• 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,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: 30AT335
• Device Catalogue Number: 30AT335
• Device Lot Number: 63873017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female