MAUDE Adverse Event Report: ZIMMER DENTAL EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH

Catalog Number	CM3113
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10.Concomitant medical products cm3113 x1, eztetic dental implant, 3.1mm diameter, 2.9mmd platform, 13mm length lot 1259353 tsvb8 x5, impl tapered scr-v sbm 3.7mm 3.5mm 8mm lot 1265723 tsvb10 x2, impl tapered scr-v sbm 3.7mm 3.5mm 10mm lot 1259281 tsv4b11 x3, imp,tsv,4.1mm,sbm,11.5 lot 1260101, 1262306 tsv4b13, imp,tsv,4.1mm,sbm,13 lot 1260099 tsvtb8 x2, imp,tsv,3.7,8,mtx,mg lot 1260805 tsvtb11, imp,tsv,3.7,11.5,mtx,mg lot 1260559 tsvtb13 x2, imp,tsv,3.7,13,mtx,mg lot 1260407 tsvt4b10 x2, imp,tsv,4.1,10,mtx,mg lot 1259816 tmmb13 x6, imp tm 3.7mm mtx,13mm lot 1259841 tsx31b8 x4, tsx implant, 3.1mmd, 8mml lot 1259848 tsx37b10 x3 tsx implant, 3.7mmd, 10mml lot 1275509.
Event or Problem Description
Distributor reported that in the last order they received there are some implants with a cracked cap.No patient impact.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) cm3113, (eztetic dental implant, 3.1mm diameter, 2.9mmd platform, 13mm length) for evaluation.A visual evaluation was performed, the reported implants packaging matched the report.The implants outer vials tamper seals were not broken.The outer vials blue cap(s) were fractured.The coob is confirmed.Device history record (dhr) review was completed for the subject lot number 1259353.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 1259353 for similar events and 1 other relevant complaint(s) was identified.Review completed utilizing keywords: dental: packaging: damaged.The customer did submit images for the reported event.The images showed the implant outer vials green cap was cracked.Based on the investigation and according to the capa, the most likely root cause determined from the investigation was external factors (temperature).This is an ongoing issue which is currently being monitored.Non-conformance and health hazard evaluation have been opened to further contain affected products, evaluate potential root causes, and consider applicable corrective actions.Therefore, based on the available information, a packaging malfunction did occur.The implants cap was cracked while the caps tamper seal was intact.The reported event/coob was confirmed.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: EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH
• 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: 20961714
• Report Number: 0002023141-2024-04037
• Device Sequence Number: 8244442
• Product Code: DZE
• UDI-Device Identifier: 00889024343603
• UDI-Public: (01)00889024343603(17)271025(10)1259353
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K142082
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: Health Professional
• Device Catalogue Number: CM3113
• Device Lot Number: 1259353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• 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: 12/18/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic