MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL IMPLANT

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Type  malfunction  

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: 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.(b)(4).Event date not provided/unknown.Device brand name unknown.Device product code unknown.Device lot number and catalog number not provided/unknown.Device not returned for evaluation.

Event Description

It was reported the healing collar (hc455) would not seat all the way on an unknown zimmer implant.The implant was cross threaded and stripped.A thread tap was needed to re-tap the implant.The implant was a tsv 4.7mm but they did not have an item number.

• Type of Device: DENTAL IMPLANT
• 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: 7421466
• MDR Text Key: 105519103
• Report Number: 0001038806-2018-00374
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• 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