MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT

Model Number	755713
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information was not provided and if it becomes available, a follow-up report will be submitted.
Event or Problem Description
Per complaint (b)(4), patient experienced loss or failure of implant to integrate.
Additional Manufacturer Narrative
"follow-up submitted to report device evaluation.Patient information was not available.When information becomes available, a supplemental report will be filed.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412".

• Brand Name: REACTIVE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9464676
• Report Number: 3001617766-2019-05723
• Device Sequence Number: 2146672
• Product Code: DZE
• UDI-Device Identifier: 10841307103769
• UDI-Public: 10841307103769
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K080713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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 Expiration Date: 04/15/2015
• Device Model Number: 755713
• Device Catalogue Number: 755713
• Device Lot Number: 26327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention