MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL SCREW

Device Problem Fracture (1260)

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

Event Date 05/17/2017

Event Type  Injury  

Event Description

It was reported the post screw fractured at tooth site # 9.An attempt to remove it was done with no luck.The patient went a few times to get the post screw out.Bone or tissue had to cleared away from the implant platform.The post screw was removed but implant remained in place.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).A4: patient weight unknown / not provided.D1: brand name unknown / not provided.D4: catalog number unknown / not provided.D4: lot number unknown / not provided.D4: unique identifier (udi) number unknown / not provided.D10.Tsvb11, impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm / 63373115.E1: reporter email address unknown / not provided.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Type of Device: DENTAL SCREW
• 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: 18536886
• MDR Text Key: 333158293
• Report Number: 0002023141-2024-00084
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: 5645646
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• 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 TSVB11 LOT 63373115
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic