MAUDE Adverse Event Report: ZIMMER DENTAL TSV BELLATEK ENCODE HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 5MM (H)

Catalog Number	TEHA4505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient weight is not provided / unknown.Initial reporter¿s title is not provided / unknown.
Event or Problem Description
Doctor reports that the teha4505 abutment was locked into the implant, nothing could get it off.The implant itself ended up losing integration while trying to get the abutment off.Either the implant or the abutment was stripped.Tooth site # 30.The implant is reported as a concomitant device.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined this mdr was not filed under the current mfr number.This event will be reported on 0001038806 - 2021 - 00107.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: TSV BELLATEK ENCODE HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 5MM (H)
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10764332
• Report Number: 0002023141-2020-01817
• Device Sequence Number: 3125169
• Product Code: NHA
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173374
• 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): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TEHA4505
• Device Lot Number: 1223932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TSVTWB10; TSVTWB10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR