MAUDE Adverse Event Report: BIOMET 3I BELLATEK ABUTMENT TSV 4.5MM

Model Number	TSVLDAT4
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient's weight is unknown.Event date is unknown.Title of report is unknown.Additional 510(k) number is k143505.Product has not yet been returned.
Event or Problem Description
It was reported that the abutment and crown came loose in the patient's mouth.Attempted abutment placement into a different implant and there was no friction fit engaging.No injury to the patient noted.Patient will return for a new prosthesis.Tooth #19.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
Additional information received from the device investigation confirmed that mhlas abutment screw will need to filed separately from the bellatek abutment (tsvldat4).Upon reassessment of the reported event, it was determined that this loosening event was filed under the incorrect device (tsvldat4) and therefore, incorrect manufacturing site, mfr number (0001038806- 2020 -01694) on 30 oct 2020.As a result, the event has been reassessed and is being filed under the correct mfr number (0002023141-2021 -00357).As a result, no further medwatch reports will be submitted for tsvldat4.Please refer to mfr# 0002023141-2021-00357) for follow up submissions and investigation results.Sections updated: b4: date of this report g4: date additional information was received by manufacturer.G7: type of report and follow up number.H2: follow up type.H10 manufacturer's narrative.

• Brand Name: BELLATEK ABUTMENT TSV 4.5MM
• Common Device Name: ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10762945
• Report Number: 0001038806-2020-01694
• Device Sequence Number: 1048047
• Product Code: NHA
• UDI-Device Identifier: 00844868038092
• UDI-Public: (01)00844868038092(10)8518272-1(241)TSVLDAT4
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K071439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: Lay User/Patient
• Device Model Number: TSVLDAT4
• Device Catalogue Number: TSVLDAT4
• Device Lot Number: 8518272-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR