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

Model Number	6534-63-15SK
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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), within distribution warehouse- ncmr was created because the label was peeling off the abutment kit.

• 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
• MDR Report Key: 9859251
• Report Number: 3001617766-2020-02894
• Device Sequence Number: 19691189
• Product Code: NHA
• UDI-Device Identifier: 10841307117681
• UDI-Public: 10841307117681
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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: 03/02/2021
• Device Model Number: 6534-63-15SK
• Device Catalogue Number: 6534-63-15SK
• Device Lot Number: 75331
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 03/20/2020
• 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