MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 3MM; HEALING ABUTMENT

Model Number	HC333
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that the healing collar can't be screwed.Another healing collar held at the dental office was placed.
Additional Manufacturer Narrative
It was reported that.Another healing collar held at the dental office was placed.Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the as returned products identified signs of use and damages on the threads.The device was located on tooth site #29 and removed same day.X-ray or picture was not provided.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported that the healing collar could not be screwed.The reported complaint was confirmed.A definitive root cause for this complaint could not be determined.The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes.' h3: device evaluated by manufacturer: change ¿no' to 'yes.'.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X3.5, 3MM
• Common Device Name: HEALING 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: 12494394
• Report Number: 0002023141-2021-02597
• Device Sequence Number: 3695058
• Product Code: NHA
• UDI-Device Identifier: 00889024014978
• UDI-Public: (01)00889024014978(17)251022(10)2020100855
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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: Health Professional
• Device Expiration Date: 10/22/2025
• Device Model Number: HC333
• Device Catalogue Number: HC333
• Device Lot Number: 2020100855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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: Unknown