MAUDE Adverse Event Report: TITAN IMPLANTS, INC TITAN DENTAL IMPLANT SYSTEM; ENDOSSEOUS DENTAL IMPLANT

Model Number	BC-45S8S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Dental implant did not osseointegrate.Radiographs are missing.Repeated attempts to obtain were made.

• Brand Name: TITAN DENTAL IMPLANT SYSTEM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): TITAN IMPLANTS, INC; 18 columbia ave; bergenfield NJ 07621
• MDR Report Key: 9294064
• Report Number: 3003024548-2019-00013
• Device Sequence Number: 2131481
• Product Code: DZE
• UDI-Device Identifier: 00842448101464
• UDI-Public: 00842448101464
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BC-45S8S
• Device Lot Number: 15005-5S483-001958-S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1