MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 5MM; HEALING COLLAR

Catalog Number HC335

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Age and date of birth unknown/not provided.Weight unknown/not provided.Product not returned to manufacturer.

Event Description

It was reported that the doctor thinks the threads of the healing collar ((b)(4)) was damaged during a procedure.

Manufacturer Narrative

No device was returned for evaluation.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 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 without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A singular cause cannot be determined.The following sections have been updated: udi: (b)(4).Device evaluated by mfr: changed "no" to "yes".

• Brand Name: HEAL COLLAR 3.5X3.5, 5MM
• Type of Device: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 6221 el camino real; carlsbad CA 92009
• MDR Report Key: 7552443
• MDR Text Key: 109493074
• Report Number: 0002023141-2018-00011
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: HC335
• Device Lot Number: 63728833
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1