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

Catalog Number	653706
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight not provided.Customer will be contacted.
Event or Problem Description
As per complaint (b)(4) during a clinical procedure a dental implant displayed a loss of osseointegration and the implant was explanted.
Event or Problem Description
As per complaint (b)(4) during a clinical procedure a dental implant displayed a loss of osseointegration and the implant was explanted.
Additional Manufacturer Narrative
Correction to sections.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d4 for catalog # and unique identifier (udi) #, d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.Device received is different from the part that was indicated on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.Lot number information is unknown.Pma/510(k) number not applicable.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: INTERACTIVE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 10264755
• Report Number: 3001617766-2020-05210
• Device Sequence Number: 3004628
• Product Code: DZE
• UDI-Device Identifier: 10841307106395
• UDI-Public: 10841307106395
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2021

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: 07/15/2020
• Device Catalogue Number: 653706
• Device Lot Number: 66261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020; 08/06/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/13/2020; 03/17/2021
• 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
• Patient Age: 63 YR