MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 4 IMPLANT; DENTAL IMPLANT

Catalog Number	875206
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Edema (1820); Failure of Implant (1924); Inflammation (1932); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption # e2012017 report late due to asr to individual reporting transition.
Event or Problem Description
Per complaint (b)(4), during post operative check, patient experienced loss or failure of implant to integrate due to error in surgical protocol.

• Brand Name: LEGACY 4 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: 8979514
• Report Number: 3001617766-2019-01418
• Device Sequence Number: 3275635
• Product Code: DZE
• UDI-Device Identifier: 10841307103011
• UDI-Public: 10841307103011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2020
• Device Catalogue Number: 875206
• Device Lot Number: 65328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 09/10/2019
• 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: 55 YR