MAUDE Adverse Event Report: ZIMMER DENTAL; IMPLANT PLACEMENT DRIVER

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the implant and mount fell down from the driver during the placement procedure.Procedure was completed, patient will not have to return to the practice to complete it.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Additional information received confirmed the device was previously submitted under mfr-0002023141-2020-02426.As a result, no further medwatch reports will be submitted under this file.

Event Description

New information received, mount did not separate from the instrument but from the implant.Implant and mount are a bundle.

• Type of Device: IMPLANT PLACEMENT DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11090019
• MDR Text Key: 224247827
• Report Number: 0002023141-2020-02426
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR