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

Catalog Number	103708
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's identifier, age, weight, date of event were 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), before clinical procedure, patient experienced failure of implant to osseointegrate.
Additional Manufacturer Narrative
Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: SCREWPLANT IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 11862567
• Report Number: 3001617766-2021-02893
• Device Sequence Number: 14246105
• Product Code: DZE
• UDI-Device Identifier: 10841307104902
• UDI-Public: 10841307104902
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2022

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: 07/09/2023
• Device Catalogue Number: 103708
• Device Lot Number: 119156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 08/10/2021; 09/22/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 08/25/2021; 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female