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

Catalog Number HC563

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Device lot number not provided.Device not returned to manufacturer for evaluation.

Event Description

It was reported that the healing collar (hc563) would not seat into the implant correctly.The implant was replaced with another implant during the same surgery and the healing collar seated correctly.

Manufacturer Narrative

No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.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.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.Without the returned product, there is not enough evidence to form a conclusion on the reported event and is therefore, non-verifiable.A singular cause cannot be identified.

• Brand Name: HEAL COLLAR 5.7X6.5, 3MM
• Type of Device: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• Manufacturer (Section G): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 7152141
• MDR Text Key: 96024864
• Report Number: 0001038806-2017-00954
• 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: 01/18/2018

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 Catalogue Number: HC563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/12/2018
• Supplement Dates FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1