MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX,13MM; DENTAL IMPLANT

Catalog Number	TMM4B13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an implant fractured at the bottom during surgical procedure at tooth site #15 applying normal torque.Procedure was complete with another implant.Both parts of the implant were removed.Patient suffered 1 hour delay at the treatment.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A4: patient weight unknown / not provided.G4: premarket identification: k113753|k112160.
Additional Manufacturer Narrative
Zimvie complaint number cmp (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.It was reported an implant fractured at the bottom during surgical procedure at tooth site #15 applying normal torque.Procedure was completed with another implant.Both parts of the implant were removed.Patient suffered one (1) hour delay at the treatment.Zimvie received one (1) tmm4b13, (imp tm 4.1mm mtx,13mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use and was attached to its bundle mount.The implant was fractured at the bottom part.The remaining fractured part was returned.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 1232412.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 1232412 for similar events and no other complaint was identified.Review completed utilizing keywords: fracture implant.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is excessive torque applied during placement.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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,13MM
• 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: 19100137
• Report Number: 0002023141-2024-01163
• Device Sequence Number: 15270883
• Product Code: DZE
• UDI-Device Identifier: 00889024018822
• UDI-Public: (01)00889024018822(17)240923(10)1232412
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: Lay User/Patient
• Device Expiration Date: 09/22/2024
• Device Catalogue Number: TMM4B13
• Device Lot Number: 1232412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic