MAUDE Adverse Event Report: EXCELL DENTAL IMPLANTS/ABENAIM TRADEMARK ENTERPRISES LLC. POWERBAL SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number POWERBALL SCREW

Patient Problem Failure of Implant (1924)

Event Date 01/22/2024

Event Type  malfunction  

Event Description

Bridge on dental implants was placed, and screws broke.Found out that the screws that were used are not fda registered.The package shows medical device status, but is not registered with fda.This company is not compliant with fda regulations.Packaging shows no lot number, no product reference or size.

• Brand Name: POWERBAL SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): EXCELL DENTAL IMPLANTS/ABENAIM TRADEMARK ENTERPRISES LLC.; 1111 goffle rd; hawthorne NJ 07506
• MDR Report Key: 18781659
• MDR Text Key: 336360835
• Report Number: MW5151965
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: POWERBALL SCREW
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White