MAUDE Adverse Event Report: A.B.DENTAL DEVICES LTD. A.B.DENTAL DEVICES DENTAL IMPLANT SYSTEM; ENDOSSEOUS DENTAL IMPLANT ABUTMENT.

Model Number I5

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2020

Event Type  Injury  

Event Description

Dental implant that was implanted in the patient mouth on 2014 broke suddenly after more than 6 years in the mouth.

• Brand Name: A.B.DENTAL DEVICES DENTAL IMPLANT SYSTEM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT ABUTMENT.
• Manufacturer (Section D): A.B.DENTAL DEVICES LTD.; 19 hayahalomim str.; ashdod, 77611 16; IS 7761116
• Manufacturer (Section G): A.B. DENTAL DEVICES LTD.; 19 hayahalomim str.; ashdod, 77611 16; IS 7761116
• Manufacturer Contact: gabi krauss ; 19 hayahalomim str.; ashdod, 77611-16 ; IS 7761116
• MDR Report Key: 10475992
• MDR Text Key: 205085745
• Report Number: 3005663340-2020-00001
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: I5
• Device Catalogue Number: I5-5,13
• Device Lot Number: 42413079293-0038
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 80