MAUDE Adverse Event Report: ZIMMER DENTAL; IMPLANT REMOVAL TOOL

Device Problem Fracture (1260)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint number (b)(4).E1: phone number: (b)(6).

Event Description

It was reported that during implant placement, the implant does not go fully down and had to be removed.During removal the driver fractured.Procedure was completed placing other implant tsv6b11.

Event Description

It was reported that during implant placement, the implant does not go fully down and had to be removed.During removal the removal tool fractured.Procedure was completed placing other implant (b)(6).

Manufacturer Narrative

Based on updated customer information received and reassessment of the reported event, it was determined that mfr report number 0002023141-2024-00079 was reported in error.Please disregard this submission.No further reports will be submitted for this event.The following sections have been updated: b4: date of this report b5: event description d1: brand name g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h10: added manufacturer narrative.

• Type of Device: IMPLANT REMOVAL TOOL
• 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 ; 5619713230
• MDR Report Key: 18522202
• MDR Text Key: 332993952
• Report Number: 0002023141-2024-00079
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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 Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic