MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX,10MM; DENTAL IMPLANT

Catalog Number	TMM4B10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided g4: premarket identification pma/510(k) #: k113753|k112160.
Event or Problem Description
Doctor reported that in the same session, a patient was scheduled with 2 tabecular metal implants.The implants were post extractional in quadrant 3.The doctor placed the first trabecular metal on tooth 36 with no problems.After that, he wanted to place the second trabecular implant on tooth 35.He took it from the package, he placed the implant in the socket , but the implant wasn't going forward.He removed the implant from the socket to see what is happening and saw that the apical part was fractured and blocked in the alveolus.He struggled hard to remove the apical part remained in the alveolus.The procedure was completed with another implant: tsv6b10.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) tmm4b10, (imp tm 4.1mm mtx,10mm), for evaluation.Visual evaluation was performed, a fracture has been identified on the implants bottom.Device history record (dhr) review was completed for the subject lot number 1273166.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 1273166, for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : implant.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was clinician selects implant that is unable to resist long-term occlusal loading.Therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the bottom.The reported event was 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.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP TM 4.1MM MTX,10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 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: 21879842
• Report Number: 0002023141-2025-01030
• Device Sequence Number: 8742115
• Product Code: DZE
• UDI-Device Identifier: 00889024018808
• UDI-Public: (01)00889024018808(17)281119(10)1273166
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K132258
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: TMM4B10
• Device Lot Number: 1273166
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2025
• 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: 04/22/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic