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

Model Number	405708
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information are not applicable as there was no patient involvement.Relevant tests/lab actions are in process.Relevant history is not applicable.Implant and explant dates are not applicable as there was no patient involvement.
Event or Problem Description
As per complaint (b)(4), during a review of finished goods in the implant direct distribution center it was discovered that a cap label contained the wrong part number & platform diameter.The product information on the label was printed as 423208 part number and 4.0mm diameter.The product information on the label should have been 405708 part number and 5.0mm diameter.

• Brand Name: SCREWINDIRECT IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 9782223
• Report Number: 3001617766-2020-00591
• Device Sequence Number: 2788129
• Product Code: DZE
• UDI-Device Identifier: 10841307104858
• UDI-Public: 10841307104858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: Other
• Device Expiration Date: 05/13/2024
• Device Model Number: 405708
• Device Catalogue Number: 405708
• Device Lot Number: 140502
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: Other