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

Catalog Number	933310
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Failure of Implant (1924)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient's dental implant failed to integrate.The patient swallowed and egested the implant, but did not experience any serious effects as a result.

• Brand Name: SWISHTAPERED IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING, LLC; 3050 east hillcrest drive.; thousand oaks CA 91362
• MDR Report Key: 8127301
• Report Number: 3001617766-2018-00354
• Device Sequence Number: 2166029
• Product Code: DZE
• UDI-Device Identifier: 10841307106340
• UDI-Public: 10841307106340
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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: 05/25/2022
• Device Catalogue Number: 933310
• Device Lot Number: 95192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 12/03/2018
• 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: 71 YR