MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC OVERDENTURE GOLD/PLASTIC COPING; DENTAL IMPLANT

Catalog Number	1000-67
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight is unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(4), during clinical procedure, fracture of bone was observed.
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 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: OVERDENTURE GOLD/PLASTIC COPING
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: marcos gutierrez ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443315
• MDR Report Key: 15456584
• Report Number: 3001617766-2022-04562
• Device Sequence Number: 12482844
• Product Code: NHA
• UDI-Device Identifier: 10841307109143
• UDI-Public: 10841307109143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 08/21/2023
• Device Catalogue Number: 1000-67
• Device Lot Number: 121768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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 Age: 63 YR
• Patient Sex: Female