MAUDE Adverse Event Report: ZIMMER DENTAL ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE; DENTAL ABUTMENT

Model Number	HLA4/5
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Pma/510k: k013227, k953101.
Event or Problem Description
It was reported abutment screw slip.1 implant of 4.7x8mm was implanted at the missing tooth site of 19 on (b)(6) 2020.The abutment screw slip was found on (b)(6) 2021.The crown and the abutment were removed.There was no impact on implant.Other abutment has been used to complete the subsequent surgery.
Additional Manufacturer Narrative
Based on updated customer information received and reassessment of the reported event, it was determined that mfr report number 0002023141-2022-02273 was reported in error.Please disregard this submission.No further reports will be submitted for this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE
• 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: 15331764
• Report Number: 0002023141-2022-02273
• Device Sequence Number: 6439486
• Product Code: DZE
• UDI-Device Identifier: 00889024015210
• UDI-Public: (01)00889024015210(17)240507(10)2019050218
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011028
• 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): 01/17/2023

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: 05/07/2024
• Device Model Number: HLA4/5
• Device Catalogue Number: HLA4/5
• Device Lot Number: 2019050218
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2019
• 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: 42 YR
• Patient Sex: Male