MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 5MM; DENTAL ABUTMENT

Model Number	HC335
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age at time of the event, weight, email address unknown / not provided.
Event or Problem Description
Doctor reported that healing collar could not be screwed during uncovering.A new healing collar was placed without any problems.Tooth site 14.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).One heal collar 3.5x3.5, 5mm (hc335) was returned for investigation.Visual evaluation of the as returned products identified some signs of use and damaged threads.Functional testing to recreate the reported event could be performed by using in-house compatible implant and the healing collar could not be threaded.Device history record (dhr) review was completed for the subject lot number 2019021179.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 by lot number (2019021179) was performed for similar event using keyword does not seat and no other similar complaint was identified.Therefore, based on the available information, device malfunction has occurred and the reported event was confirmed.

• Brand Name: HEAL COLLAR 3.5X3.5, 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: 12340731
• Report Number: 0002023141-2021-02201
• Device Sequence Number: 4632936
• Product Code: NHA
• UDI-Device Identifier: 00889024014985
• UDI-Public: (01)00889024014985(17)240219(10)2019021179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111852
• 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): 11/17/2021

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: Health Professional
• Device Expiration Date: 02/19/2024
• Device Model Number: HC335
• Device Catalogue Number: HC335
• Device Lot Number: 2019021179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• 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: 07/30/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female