MAUDE Adverse Event Report: ZIMMER DENTAL 30 DEG TAPER 4.5P 4MM-6MM; DENTAL ABUTMENT

Model Number	30AT446
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Patient weight unknown /not provided.
Event or Problem Description
It was reported that patient was implanted with multiple implants, and immediately loaded and wore temporary crowns in the afternoon.There was no adverse reaction after the operation.Six months later, when the patient returned to the clinic, it was found that the screw was deformed due to loose abutment, which could not be locked with additional force, resulting in failure, so it was removed.The corresponding implant model is tsv4b13 with the batch of 63799424.Tooth site # 25.
Additional Manufacturer Narrative
One (1) 30 deg taper 4.5p 4mm-6mm (30at446) was returned for investigation visual evaluation of the returned product identified signs of use.Also, an associated product (tsv4b13) 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.Functional testing to recreate the reported event identified that the tapered abutment and retaining screw engaged and disengaged from an in-house implant as intended.The retaining screw, however, didn¿t disengage from the abutment.A pre-existing condition noted on the per was inadequate oral hygiene.Bone density was low density (type iii).The reported device was located on tooth # 25 (fdi) and was used for approximately six (6) months.The customer did not provide any images for the reported event.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 63792197.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, were 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 63792197 for similar events and other 1 relevant complaint(s) was identified, (b)(4).February post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.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 occur (damaged screw).However, the reported loosening event could not be verified.The following sections have been updated: h3: changed "no" to "yes".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 30 DEG TAPER 4.5P 4MM-6MM
• 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: 16197911
• Report Number: 0002023141-2023-00215
• Device Sequence Number: 5794693
• Product Code: DZE
• UDI-Device Identifier: 00889024013612
• UDI-Public: (01)00889024013612(17)220930(10)63792197
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: 30AT446
• Device Catalogue Number: 30AT446
• Device Lot Number: 63792197
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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
• Patient Age: 40 YR
• Patient Sex: Male