MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 3MM; HEALING COLLAR

Model Number	HC343
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Doctor indicated that healing abutment does not disengage from the implant.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
Doctor indicated that healing abutment does not disengage from the implant.Doctor confirmed that new implant was placed to complete the procedure.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One heal collar 3.5x4.5, 3mm (hc343) and one imp,tsv,mcol mg,3.7mm,11.5mml (tsvmb11) were returned for investigation connected to one another.Visual inspection of the as returned product identified signs of wear and significant debris about the healing collar and implant.Functional testing was performed for the returned product and it was determined the two components could not be disengaged unless excessive force was taken.The removed healing collar is noted to show signs of thread damage at the first and second threads.No pre-existing conditions were noted on the product experience report per).The reported product was located on tooth number 35 (fdi) and used for approximately 3 months.A device history review was performed and no related nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional complaints for this lot.The complaint reported doctor indicated that healing abutment does not disengage from the implant.The customer has not provided additional pictures or x-ray images of the product.The reported event is confirmed following functional testing of the returned product.A definitive root cause could not be identified.

• Brand Name: HEAL COLLAR 3.5X4.5, 3MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9523044
• Report Number: 0002023141-2019-01369
• Device Sequence Number: 11438929
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)230427(10)2018042069(241)HC343
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: HC343
• Device Catalogue Number: HC343
• Device Lot Number: 2018042069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 12/06/2019; 12/06/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/06/2020; 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 80