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

Catalog Number	854710
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), a dental implant was stuck while screwing during clinical procedure.The dentist tried to remove the implant by unscrewing it, but he could not unscrew it with normal instruments.The implant was removed by grasping with forceps.Consequently, the implant was broken.The initial placement procedure was completed within the same day.The patient did not experience adverse consequences.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Returned device was not the same part as previously reported.Updated device family, part number and udi number.

• Brand Name: LEGACY 3 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e. hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8157218
• Report Number: 3001617766-2018-00368
• Device Sequence Number: 2363528
• Product Code: DZE
• UDI-Device Identifier: 10841307106463
• UDI-Public: 10841307106463
• 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: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2022
• Device Catalogue Number: 854710
• Device Lot Number: 92409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR