MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 5.7X6.5, 3MM; DENTAL HEAL COLLAR

Model Number	HC563
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that during uncovering both healing collars could not be screwed in the implants threads (maybe threads problem of implant).Procedure was completed using other healing collars but only temporary.Tooth location: 36.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
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 healing collars (hc565 & hc563) were returned for investigation.Visual evaluation of the as returned products identified damage around the threads.Functional testing was performed using an applicable in-house implant.The devices could not be threaded fully into the implant due to thread damage.Device history record (dhr) review for the lots (2020031535 & 2021020192) 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.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2020031535 & 2021020192) for similar events (complaint category keywords: does not seat) and no other complaint was identified.Therefore, based on the available information, healing collar malfunction did occur and the reported event was confirmed.

• Brand Name: HEAL COLLAR 5.7X6.5, 3MM
• Common Device Name: DENTAL HEAL COLLAR
• 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: 12786054
• Report Number: 0002023141-2021-03164
• Device Sequence Number: 4018468
• Product Code: NHA
• UDI-Device Identifier: 00889024015111
• UDI-Public: (01)00889024015111(17)260204(10)2021020192
• 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): 02/22/2022

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: 02/04/2026
• Device Model Number: HC563
• Device Catalogue Number: HC563
• Device Lot Number: 2021020192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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 Age: 36 YR
• Patient Sex: Male