MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL SCREW

Device Problem Fracture (1260)

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

Event Date 10/22/2023

Event Type  Injury  

Event Description

Doctor reported that the screw fractured inside the implant and was removed.Procedure not completed.

Manufacturer Narrative

Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.D1: brand name unknown / provided.D4: additional device information unknown / not provided.D4: unique identifier (udi) number not available.E1: reporter name unknown / not provided.G4: premarket identification unknown / not provided.H4: device manufacturer date unknown / not provided.

• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18896973
• MDR Text Key: 337585154
• Report Number: 0002023141-2024-00704
• Device Sequence Number: 1
• Product Code: NHA
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic