MAUDE Adverse Event Report: BIOMET 3I TSV BELLATEK ENCODE HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 5MM (H)

Model 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 (b)(4).Patient weight is not provided / unknown.Initial reporter¿s title is not provided / unknown.The reported device was received for evaluation.The reported condition of abutment (reported device) locked into the implant (concomitant), was confirmed.Visual evaluation of the as returned products identified signs of wear (nicks and bone residue) due to usage.The abutment was severely damaged possibly during removal.The devices were still engaged.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.A device history record (dhr) review was completed for the reported device lot.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported event was noted as part of the dhr.A complaint history review was completed for the reported device lot for similar event and no other complaint was identified.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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.

• 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): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11216527
• Report Number: 0001038806-2021-00107
• Device Sequence Number: 19725495
• Product Code: NHA
• UDI-Device Identifier: 00844868040958
• UDI-Public: (01)00844868040958(17)240123(10)1223932(241)TEHA4505
• 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
• 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 Expiration Date: 01/23/2024
• Device Model Number: TEHA4505
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR