MAUDE Adverse Event Report: ZIMMER DENTAL ABUT,ZIR,ANG,4.5MM,6.0MM,; DENTAL ABUTMENT

Model Number	ZRA461A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported loosening in the crown.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative one abut, zir, ang,4.5mm,6.0mm, (zra461a) and crown were returned for investigation.Visual evaluation of the as returned products identified fracture around the ceramic portion of one abutment.The abutment presented signs of wear/use and the crowns was detached.Functional testing was not performed due to the nature of the device and events.No pre-existing conditions were noted.The reported devices had been placed on tooth 35 & 36 (fdi) for an unknown amount of time.Device history record (dhr) review for the lot (2020110414) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2020110414) for similar events (complaint category keywords: loosening & fracture) and 1 other complaint was identified.October post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information, device malfunction did occur for one abutment and fracture was confirmed.However, no malfunction was identified for the other abutment and loosening could not be verified as the exact details of event were unknown/nonverifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ABUT,ZIR,ANG,4.5MM,6.0MM,
• 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: 12407630
• Report Number: 0002023141-2021-02392
• Device Sequence Number: 5292700
• Product Code: NHA
• UDI-Device Identifier: 00889024021549
• UDI-Public: (01)00889024021549(17)991231(10)2020110414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083474
• 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): 12/08/2021

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: Lay User/Patient
• Device Model Number: ZRA461A
• Device Catalogue Number: ZRA461A
• Device Lot Number: 2020110414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• 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: 08/10/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Female