MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 3.7MM MTX FULL,10M; DENTAL IMPLANT

Catalog Number	TMTB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Osteolysis (2377)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #14 was removed due to being fractured & peri-implantitis.Patient presented for re evaluation on (b)(6) 2025.Swollen gums & purulent exudate noted on buccal next to the implant; opened flap, bone loss on buccal 6mm.Mobility of the implant removed broken/fractured part of the implant.Left remnants of the integrated part of the implant & disengaged apical part of the implant due to sinus cavity involvement.Symptoms as a result of the event: abscess & inflammation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).H6: additional h6- patient codes: (b)(6): inflammation.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) tmtb10, (imp tm 3.7mm mtx full,10m) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent minor bone / tissue attached to external threads.The implant was observed fractured at the body.Functional testing to recreate the reported events could not be performed due to the nature of the device & events.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1280132.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1280132 for similar events and no other complaint was identified.The customer did submit two (2) x-ray images for the reported events.Based on the investigation and risk management file review as per rmf (b)(4) rev.5, the most likely root causes determined from the investigation are parafunctional habits / patient factors.Therefore, based on the available information, a device malfunction did occur.The reported event (fracture implant) was confirmed with all the available information.Peri-implantitis is a medical condition and is non-verifiable with the information provided.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.Peri-implantitis is an infectious disease that causes inflammation of the gum and the bone structure around a dental implant.Chronic inflammation causes bone loss, which can lead to implant failure thus its removal.Investigations performed for hundreds of events where either of these conditions, infection, or bone loss, or both, have been reported, have concluded that the likely cause(s) for the implant failure in relation to these conditions are external factors.Those include medical conditions (e.G., diabetes, bruxism, etc.), patient habits (e.G., smoking, bad oral hygiene routine) and user error (e.G., surgical technique).There has not been any instance where either infection and/or bone loss, and when right conditions prevail and led to peri-implantitis whether reported or not along with the other two, have resulted from a manufacturing or design defect.Furthermore, the probability of manufacturing or design defects that might lead to infection and result in bone loss occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.The analysis and result of investigations and the analysis of probability previously described are contained in the summary investigation reports performed for bone loss and infection, which are attached.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.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.

• Brand Name: IMP TM 3.7MM MTX FULL,10M
• 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: 22678050
• Report Number: 0002023141-2025-02108
• Device Sequence Number: 9000019
• Product Code: DZE
• UDI-Device Identifier: 00889024018990
• UDI-Public: (01)00889024018990(17)290530(10)1280132
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 09/23/2025

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: Other
• Device Catalogue Number: TMTB10
• Device Lot Number: 1280132
• 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: 07/31/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic