MAUDE Adverse Event Report: BIOMET 3I; DENTAL ABUTMENT

Lot Number	1258238
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attempting to place the abutment in the patient's mouth, the abutment would not engage with the implant, it kept spinning.The implant was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Additional information was received.The implant was not removed and a new abutment was placed.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.Zimvie received one (1) teeha553, (tsv bellatek encode emergence healing abutment 5.7mm(d) 5.7mm(p) 3mm(h)) for evaluation.A visual evaluation and a functional test was performed, the abutment had signs of use.The abutment measurements matched prints.The connection type of the teeha553 is intended for zimmer implants only.The abutment seated correctly with an in-house zimmer implant as intended.Dhr review was completed for the subject lot number 1258238.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1258238 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was missing or confusing labeling or the clinician placed a healing abutment and screw in a patient with patient factors incompatible with proper soft tissue healing (e.G.Poor patient hygiene, periodontal issues, pre-existing medical conditions).However, during product evaluation it was confirmed that the abutment seated with a zimmer implant as intended.Therefore, based on the available information, device malfunction did not occur.The customer used a zimmer abutment with a biomet implant.The reported event was not confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.D4: lot number was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.
Event or Problem Description
No additional event information at the time of this report.

• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16784215
• Report Number: 0001038806-2023-00791
• Device Sequence Number: 19680635
• Product Code: DZE
• UDI-Device Identifier: 00844868045939
• UDI-Public: (01)00844868045939(17)271024(10)1258238
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Lot Number: 1258238
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 04/04/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 09/29/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT-SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic