MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL IMPLANT MOUNT

Catalog Number UNKNOWN MOUNT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Brand name is not provided / unknown.Catalog number and lot number are not provided / unknown.Initial reporter¿s title and email address are not provided / unknown.

Event Description

It was reported that the implant was dropped during placement at tooth site # 23.The mount disengaged.The procedure was completed with another implant from stock.

Event Description

No additional or corrected information to report.

Manufacturer Narrative

This report is being submitted to report additional information.The unknown transfer mount was not returned.The reported event is non-verifiable.Based on the evaluation mount malfunction could not be verified.There is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that could cause or contribute to the reported event.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and likely conforming when they left zimmer biomet.Dhr review could not be performed, as the lot number associated with the reported product unknown mount is not available.No complaint history review could be performed without relevant lot and item information for the unknown mount.Functional testing to recreate the reported event could not be performed due to the mount not being returned.The reported event could not be recreated due to the nature of the dental device and event and the complaint is related to the functional performance of the device.A definitive root cause could not be identified.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.H3 other text : no item or lot number provided.

• Type of Device: DENTAL IMPLANT MOUNT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12747055
• MDR Text Key: 281214417
• Report Number: 0002023141-2021-03112
• 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,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN MOUNT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male