MAUDE Adverse Event Report: OSSTEM CO., LTD. OSSTEM IMPLANT SYSTEM; DENTAL IMPLANT

Model Number	TS3S5013S
Medical Device Problem Code	Inadequate Ultra Filtration (1656)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
Cover screw would not disengage from the dental implant.

• Brand Name: OSSTEM IMPLANT SYSTEM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): OSSTEM CO., LTD.; 66-16, bansong-ro 513beon-gil; haeundae-gu; busan, busan gwangyeogsi 612-0 70; KS 612-070
• MDR Report Key: 12239033
• Report Number: 3003394081-2021-00001
• Device Sequence Number: 14702943
• Product Code: DZE
• UDI-Device Identifier: 08800000963914
• UDI-Public: 08800000963914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace,Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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 Model Number: TS3S5013S
• Device Catalogue Number: BTS3S5013S
• Device Lot Number: FTP20L061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1