MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY OVERDENTURE ABUTMENT; DENTAL IMPLANT

Catalog Number	8035-62
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	04/17/2020
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.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.
Event or Problem Description
Per (b)(4), patient experienced discomfort.When the upper structure was removed, it was found that abutment screw was fractured.
Additional Manufacturer Narrative
This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).

• Brand Name: LEGACY OVERDENTURE ABUTMENT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 10535036
• Report Number: 3001617766-2020-06342
• Device Sequence Number: 10855875
• Product Code: NHA
• UDI-Device Identifier: 10841307111498
• UDI-Public: 10841307111498
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/15/2021

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: 01/23/2024
• Device Catalogue Number: 8035-62
• Device Lot Number: 132197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 03/15/2021
• 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