MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM; DENTAL IMPLANT

Catalog Number	TSVH11
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that implant vial cap broken.When the implant container was removed from the case, the cap (green) was cracked.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number k013227.
Additional Manufacturer Narrative
Zimvie received one (1) tsvh11, (impl tapered scr-v ha 3.7 mm 3.5mm 11.5mm) for evaluation.Visual inspection was performed.Complaint was reopened since the product was returned for evaluation.The returned implant packaging / vial was identified as reported; however, the implant's outer vial green cap was observed cracked / damaged, and the tamper seal / ring was intact.The reported coob complaint was confirmed.See pictures attached.Dhr review was completed for the subject lot number 1260229.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 1260229 for similar events and one other complaint was identified (cmp-117162-2025).The customer did submit images for the reported event.See attached at the ce level.Images show the reported broken green caps.The failure mode of fractured caps on the tsv, tm, 3.1, and tsx packaging is found to be a delayed defect occurring at random outside zimvie's control.Following the supply chain of components, production, and transportation to multiple zimvie sites and eventual distribution across the world, there was no commonality between the lots that resulted in units with fractured caps and lots that yielded no fractured caps.The most probable conclusion is that the external factors such as temperature during transportation are contributing factors to the stress on the cap.Therefore, based on the available information, a device malfunction did occur.The caps were observed to be cracked in the provided photos.The coob has been confirmed.This is an ongoing issue which is currently being monitored.Nc-000849-2024 (pbg) and nc-001012-2024 (vlc), hhed-2023-00023 / hhe-2023-00021 and capa-000227-2024 have been opened to further contain affected products, evaluate potential root causes, and consider applicable corrective actions.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie did not receive one (1) tsvh11, (impl tapered scr-v ha 3.7 mm 3.5mm 11.5mm) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 1260229.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 1260229 for similar events and one other complaint was identified ((b)(4)).The customer did submit images for the reported event.Images show the reported broken green caps.The failure mode of fractured caps on the tsv, tm, 3.1, and tsx packaging is found to be a delayed defect occurring at random outside zimvie's control.Following the supply chain of components, production, and transportation to multiple zimvie sites and eventual distribution across the world, there was no commonality between the lots that resulted in units with fractured caps and lots that yielded no fractured caps.The most probable conclusion is that the external factors such as temperature during transportation are contributing factors to the stress on the cap.Therefore, based on the available information, a device malfunction did occur.The caps were observed to be cracked in the provided photos.The coob has been confirmed.This is an ongoing issue which is currently being monitored.(b)(4) (pbg) and (b)(4) (vlc), hhed-2023-00023 / hhe-2023-00021 and capa-000227-2024 have been opened to further contain affected products, evaluate potential root causes, and consider applicable corrective actions.Therefore, based on the available information, reported malfunction did occur, and 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.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up." h6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM
• 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: 22586313
• Report Number: 0002023141-2025-02034
• Device Sequence Number: 4565092
• Product Code: DZE
• UDI-Device Identifier: 00889024019577
• UDI-Public: (01)00889024019577(17)280124(10)1260229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061410
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

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: Other
• Device Catalogue Number: TSVH11
• Device Lot Number: 1260229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/09/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic