MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY STRAIGHT ABUTMENT FULL-CONTOUR PROFILE; DENTAL IMPLANT

Catalog Number	HLA3-5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	08/22/2020
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.Pma/510(k) - not applicable.
Event or Problem Description
Per complaint (b)(4), patient experienced loss or failure of implant to osseointegrate.
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.

• Brand Name: LEGACY STRAIGHT ABUTMENT FULL-CONTOUR PROFILE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 10611689
• Report Number: 3001617766-2020-06878
• Device Sequence Number: 11445610
• Product Code: DZE
• UDI-Device Identifier: 10841307111832
• UDI-Public: 10841307111832
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2023
• Device Catalogue Number: HLA3-5
• Device Lot Number: 107832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 02/02/2021
• 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: 55 YR