MAUDE Adverse Event Report: BIOMET 3I TSX IMPLANT, 6.0MMD, 13MML; DENTAL IMPLANT

Catalog Number	TSX6B13
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant was missing from the vial.The implant and the little post was missing.The issue was found during a procedure but had another implant available to complete the procedure.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age and date of birth unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.B3: date of event unknown / not provided.D6a: implant date unknown / not provided.D6b: explant date unknown / not provided.
Additional Manufacturer Narrative
Zimvie received empty packaging for one (1) tsx6b13, (tsx implant, 6.0mmd, 13mml) for evaluation.Visual evaluation / functional test was performed, the packaging was observed already opened.The outer vial tamper seal was broken.The inner vial only contained the cover screw, the implant and alignment pin were missing / not returned.The coob is non-verifiable as the condition of the product / packaging received by the customer is unknown / non-verifiable.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1280508.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 1280508 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : packaging : incorrect component quantity.The customer did/did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00308-pfmea, the most likely root cause determined from the investigation was improper handling of product outside of zimvie controls.Therefore, based on the available information, a device malfunction could not be verified.The implant package returned opened and empty.The reported event is non-verifiable with all the available information.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TSX IMPLANT, 6.0MMD, 13MML
• Common Device Name: DENTAL IMPLANT
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 21629794
• Report Number: 0001038806-2025-00598
• Device Sequence Number: 20920244
• Product Code: DZE
• UDI-Device Identifier: 00844868045298
• UDI-Public: (01)00844868045298(17)290507(10)1280508
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K220978
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 06/23/2025

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 Catalogue Number: TSX6B13
• Device Lot Number: 1280508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic