MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint number (b)(4).D1: brand name unknown / provided.D4: additional device information unknown / not provided.D4: unique identifier (udi) number not available.D6: implant date unknown / not provided.D10: concomitant medical product and therapy dates: tsv4b10, imp,tsv,4.1mm,sbm,10, lot number: 63826922; tsvm4b8, imp,tsv,mcol mg,4.1mm,8mm, 64020805.G4: premarket identification unknown / not provided.H4: device manufacturer date unknown / not provided.

Event Description

(b)(6) 2024.Update: implant on 36 removed due to fracture of the screw, implant on the middle removed due to fracture and implant on mesial removed due to peri implantitis.Niglesias.It was reported that 3 implants were placed at tooth sites 36/37.After 2 years, screw fractured inside the implant at 36 and had to be removed, and implants at tooth site 37 fractured at the collar of the implant.Peri-impantitis was also reported.Pain, abscess and inflammation were reported as a result of the event.

• 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: 18607492
• MDR Text Key: 334106066
• Report Number: 0002023141-2024-00180
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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: 01/18/2024
• 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
• Treatment: DENTAL IMPLANT.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 162 KG
• Patient Ethnicity: Non Hispanic