MAUDE Adverse Event Report: ZIMMER DENTAL ABUT ZIRCONIA3.5 X 4.5 1; DENTAL ABUTMENT

Model Number	ZRA341S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient came in with discomfort, and on examination of tooth location (not provided) noticed that one abutment was loose and was removed.Patient returning for replacement.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Date of event unknown / not provided.
Additional Manufacturer Narrative
Abut zirconia 3.5 x 4.5 1 (zra341s) was not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr), instructions for use (ifu), and risk file.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No pre-existing condition was noted, and no per form was provided.Bone density type is unknown.The reported devices were located on unknown tooth sites, and were used for an unknown amount of time.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot numbers (2020110413).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 (2020110413) for similar events and one (1) other relevant complaint was identified (b)(4).Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up".H2: checked follow-up type.H3: changed "yes" to "no".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report d4: unique identifier (udi) number g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ABUT ZIRCONIA3.5 X 4.5 1
• 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: 13533854
• Report Number: 0002023141-2022-00335
• Device Sequence Number: 12049086
• Product Code: NHA
• UDI-Device Identifier: 00889024021488
• UDI-Public: (01)00889024021488(10)2020110413
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061847
• 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,Followup
• Report Date (Section B): 07/26/2022

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: Lay User/Patient
• Device Model Number: ZRA341S
• Device Catalogue Number: ZRA341S
• Device Lot Number: 2020110413
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 01/24/2022; 07/25/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 07/25/2022; 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2020
• 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