MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYFIXED INTERACTIVE ANGLED; DENTAL IMPLANT

Catalog Number	6530-62-15SK
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event	03/16/2018
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.

• Brand Name: SIMPLYFIXED INTERACTIVE ANGLED
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8979689
• Report Number: 3001617766-2019-01464
• Device Sequence Number: 2922150
• Product Code: NHA
• UDI-Device Identifier: 10841307117629
• UDI-Public: 10841307117629
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• 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: 09/16/2020
• Device Catalogue Number: 6530-62-15SK
• Device Lot Number: 68388
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• 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: 53 YR