MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISH TITANIUM NON-ENGAGING TEMPORARY ABUT.; DENTAL IMPLANT

Model Number	9048-49
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was identified internally and generated for ncmr 10279.Per the ncmr, the part will be destroyed.
Event or Problem Description
Per complaint (b)(4), during an internal review, a part was identified as missing a label.

• Brand Name: SWISH TITANIUM NON-ENGAGING TEMPORARY ABUT.
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 9873302
• Report Number: 3001617766-2020-02949
• Device Sequence Number: 560884
• Product Code: NHA
• UDI-Device Identifier: 10841307116585
• UDI-Public: 10841307116585
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 05/11/2024
• Device Model Number: 9048-49
• Device Catalogue Number: 9048-49
• Device Lot Number: 142088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 03/24/2020
• 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