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

Catalog Number	606011
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Impaired Healing (2378); Osteopenia/ Osteoporosis (2651)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss of implant to integrate.
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 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.Information for section a4 was not available.When information becomes available, a supplemental report will be filed.

• Brand Name: REPLANT 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: 11495354
• Report Number: 3001617766-2021-01726
• Device Sequence Number: 5512859
• Product Code: DZE
• UDI-Device Identifier: 10841307104155
• UDI-Public: 10841307104155
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061319
• 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: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 06/03/2020
• Device Catalogue Number: 606011
• Device Lot Number: 64739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/14/2021
• 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: 75 YR