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

Catalog Number HC565

Device Problems Failure to Advance (2524); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported that he could not seat the healing abutment.

Manufacturer Narrative

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.The reported implant was not returned for inspection.The returned x-ray shows the reported implant and healing collar.It can be seen that the healing collar is not fully seated in the implant.The product was functionally tested, and it was confirmed that the collar would not screw into a mating implant.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.It is clear from the package drawing under pd-hc565 rev a that the first thread is compressed inward.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 alleged complaint is confirmed.A singular root cause cannot be determined.The following sections have been updated.(b)(4).

• Brand Name: HEAL COLLAR 5.7X6.5, 5MM
• Type of Device: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 6221 el camino real; carlsbad CA 92009
• MDR Report Key: 7545272
• MDR Text Key: 109305896
• Report Number: 0002023141-2018-00006
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: PK111852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: HC565
• Device Lot Number: 63333099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 45