MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL DRIVER

Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915)

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

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Udi number unknown / not provided.Dental implant: tsvwb10, lot number: 1253105.Item name: impl tapered scr-v sbm 4.7mm 4.5mm 10mm.Pma/510(k) number not available.No device catalog or lot number was provided so a device history record review and a complaint history review could not be performed.Since the device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted.

Event Description

It was reported that the implant on an unknown tooth site was removed because the driver damaged the implant.

• 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: 15763918
• MDR Text Key: 303389716
• Report Number: 0002023141-2022-02819
• Device Sequence Number: 1
• Product Code: NDP
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DENTAL IMPLANT.
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male