MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X5.5, 5MM; HEALING ABUTMENT

Catalog Number HC455

Device Problems Positioning Failure (1158); Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Date of event unknown / not provided.

Event Description

It was reported that the abutment would not seat fully in the patient's mouth.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified some signs of use and but no apparent malfunction identified.Functional testing to recreate the reported event could be performed by using in-house compatible implant and the healing collar threaded as its intended.Device was located on tooth location #3 for approximately 1 month and 2 weeks.X-ray or picture image was not provided.A device history record review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported that the abutment would not seat fully in the patient's mouth.The reported complaint could not be confirmed.A definitive root cause for this complaint could not be determined.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.'.

Event Description

No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X5.5, 5MM
• Type of Device: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11420908
• MDR Text Key: 241958165
• Report Number: 0002023141-2021-00539
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K111852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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: 03/12/2024
• Device Catalogue Number: HC455
• Device Lot Number: 2019030807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR