MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 14M M OCTAGON; DENTAL IMPLANT

Catalog Number	SPB14
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that the implant packaging is intact, but upon opening it, he realizes that the implant is missing from inside the packaging.No impact to the patient.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: premarket identification k011245/k002188.
Additional Manufacturer Narrative
Zimvie complaint number(b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) spb14, (impl tapered sp 3.7mm 14m m octagon) for evaluation.Visual evaluation was performed, the returned implant packaging was identified as reported.The outer box lid was observed damaged, and a piece of tape was attached to the top.The inner vial was missing / not returned, and the outer vial tamper seal / ring was broken.There was no implant inside the inner vial / not returned.Device history record (dhr) review was completed for the subject lot number 2022091314.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 2022091314 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: packaging: incorrect component quantity.Based on the investigation and risk management file review, the most likely root cause determined was likely improper handling of product outside of zimvie controls.Therefore, based on the available information, a packaging malfunction could not be verified.The implant vials tamper seal was broken.There was no implant inside the vial.The reported coob/event was non-verifiable since the condition of the product/packaging received by the customer was unknown.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.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: IMPL TAPERED SP 3.7MM 14M M OCTAGON
• 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: 22123214
• Report Number: 0002023141-2025-01474
• Device Sequence Number: 6950842
• Product Code: DZE
• UDI-Device Identifier: 00889024017191
• UDI-Public: (01)00889024017191(17)270928(10)2022091314
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082639
• 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): 08/22/2025

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: SPB14
• Device Lot Number: 2022091314
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/07/2025
• 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: 06/02/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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