MAUDE Adverse Event Report: SURGIKOR, LLC VERSATILE IMPLANT; DENTAL IMPLANT

Model Number	VRH3711
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint report was provided with much of the information required by form 3500a missing.This was despite the complaint report's prompting the provision of such information.Date of manufacture is said to be 11-1-16 in report.But we do not actually know the day, only the month and year.The program required that a day be entered, though.This report was delayed by disruptions caused by the coronavirus.
Event or Problem Description
Failure of two implants.Teeth affected were 28 and 29.Surgery necessary to prevent damage.Patient needed to return for another dental appointment to finish the procedure (i.E., replace implant).Due to event, patient experienced mild pain, and what were presumably the implants (not clear, but strongly suggested) were said to be "loose, not integrated." implants were restored.The two implants were placed too close to each other, and this is believed to have caused the failure.

• Brand Name: VERSATILE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): SURGIKOR, LLC; 1299 w. jefferson blvd; los angeles, ca
• MDR Report Key: 9892424
• Report Number: 3013173272-2020-00002
• Device Sequence Number: 19622810
• Product Code: DZE
• UDI-Device Identifier: D824PVRH37110
• UDI-Public: +D824PVRH37110/$$714705/14D202206212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: 06/21/2022
• Device Model Number: VRH3711
• Device Lot Number: 14705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/28/2020
• 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: 81 YR