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

Catalog Number HC563

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 03/13/2018

Event Type  malfunction  

Event Description

It was reported that the doctor was unable to seat the healing collar (hc563).

Manufacturer Narrative

Zimmer biomet complaint (b)(4).One zimmer dental heal collar was returned for inspection.A visual inspection revealed wear about the collar and the threads are noted to be damaged at the engaging surface.The hex head was also slightly worn, but functional.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional related complaints against this lot.Appropriate documentation was reviewed and the following information was identified: instructions for use for healing collars, healing screws, surgical cover screws and temporary gingival cuffs 9658 rev 1-01/15.Information identified: healing collars ¿ for use with tapered screw-vent, screw-vent and trabecular metal implants select the appropriate size healing collar for the platform of the implant and with appropriate height and emergence profile to fit the existing or desired tissue contour of the site.The healing collars are anodized with color-coding on the lower portion to indicate the implant platform diameter.The top surface of the healing collar is etched with three numbers to reference implant platform diameter, emergence profile diameter and cuff height.The numbers for implant platform and emergence profile show only the initial digit of the related measurement.The product was functionally tested, and it was confirmed that the collar would not screw into a mating implant.It is clear from the package drawing under pd-hc34563 rev a that the first two threads are compressed upward.The problem with screwing in the collar appears to be due to this damage, as the orientation of the engaging threads does not match the drawing and are deformed due to this damage.The complaint is confirmed.A singular cause cannot be determined.(b)(4).

• Brand Name: HEAL COLLAR 5.7X6.5, 3MM
• Type of Device: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 6221 el camino real; carlsbad CA 92009
• Manufacturer (Section G): ZIMMER DENTAL; 6221 el camino real; carlsbad CA 92009
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 7437117
• MDR Text Key: 105889846
• Report Number: 0001038806-2018-00419
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: HC563
• Device Lot Number: 2017111345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 08/07/2018
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR