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

Model Number	715713
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information was not provided and if it becomes available, a follow-up report will be submitted.
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced failure of implant to integrate.

• Brand Name: REPLUS IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 9847217
• Report Number: 3001617766-2020-02807
• Device Sequence Number: 19023731
• Product Code: DZE
• UDI-Device Identifier: 10841307104568
• UDI-Public: 10841307104568
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K073161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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 Model Number: 715713
• Device Catalogue Number: 715713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/18/2020
• 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