MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1,8,MTX,MG; DENTAL IMPLANT

Catalog Number	TSVT4B8
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age and date of birth unknown / not provided.A3: patient sex unknown / not provided.A4: weight unknown / not provided.B3: date of event unknown / not provided.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during receiving/inspection of the product by the clinic, they found that the inner bottle cap was cracked immediately after taking it out of the outer box.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 111.H6: investigation conclusions code was added: 25.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation was performed, the reported implants packaging matched the report.The implants outer vials tamper seals were not broken.All the outer vials green caps were fractured.Dhr review was completed for the subject lot number.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 for similar events and no other complaint was identified.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.A capa has been opened to further contain affected products, evaluate potential root causes, and consider applicable corrective actions.Therefore, based on the pictorial evidence and available information, packaging malfunction did occur.The implants outer vials tamper seals were not broken.The implants outer vial green caps was fractured.The reported event was confirmed.

• Brand Name: IMP,TSV,4.1,8,MTX,MG
• 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: 21577135
• Report Number: 0002023141-2025-00633
• Device Sequence Number: 15641249
• Product Code: DZE
• UDI-Device Identifier: 00889024019867
• UDI-Public: (01)00889024019867(17)271027(10)1258893
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K101977
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: TSVT4B8
• Device Lot Number: 1258893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/11/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic