MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT

Catalog Number	855716
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), it was discovered during clinical procedure that a patient's dental implant fractured.Pain and inflammation were reported.The implant was explanted.

• Brand Name: LEGACY 3 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: 8928641
• Report Number: 3001617766-2019-00476
• Device Sequence Number: 268812
• Product Code: DZE
• UDI-Device Identifier: 10841307102328
• UDI-Public: 10841307102328
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2018
• Device Catalogue Number: 855716
• Device Lot Number: 45329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/24/2019
• 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: 58 YR