MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL DRIVER

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that the implant at tooth site #4 disengaged and was removed. implant was contaminated during delivery of implant dropped.New implant was placed.

Event Description

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

Manufacturer Narrative

One impl tapered scr-v sbm 3.7mm 3.5mm 10mm (tsvb10) was returned and one unknown driver was not returned for investigation.Visual evaluation of the as returned implant identified no damage to the implant.Functional testing was performed with an in-house driver and the implant and mount engaged and retained on the driver.Pre-existing conditions noted on the per were low bone density ¿ type iii.The reported device had been placed on tooth #4 (universal).X-ray & picture evaluation: picture or x-ray evidence not provided.Appropriate documentation was reviewed.Dhr review for the lot (1251442) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1251442) for similar events and no other complaint was identified.Dhr, sterilization, and complaint history review could not be performed, as the subject lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.Feb post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur (implant) and could not be verified (driver) and the reported event was non-verifiable.The following sections have been updated: g6: checked "follow-up." h3: changed "yes" to "no.".

• Type of Device: DENTAL DRIVER
• 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: 15993145
• MDR Text Key: 306256975
• Report Number: 0002023141-2022-03146
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male