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	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The delay in reporting the event occurred since it is our first time establishing an emdr account and the process took more than a month to establish.Now that the account has been established, the submissions will be submitted in a timely manner.
Event or Problem Description
Dental implant did not osseointegrate.The dentist sent titan implants a lump sum of dental implants and list of patient names; claiming the implants did not osseointegrate.Implant failure forms were provided to the dentist.Thus far, implant failure forms and radiographs are missing.No other information provided other than patient's name.

• 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: 9294053
• Report Number: 3003024548-2019-00008
• Device Sequence Number: 11356179
• 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
• 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: 09/03/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• 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