MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 10M M OCTAGON; DENTAL IMPLANT

Catalog Number	SPB10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reported that the implant was loose inside the container, poorly screwed in, and therefore fell and became contaminated.Procedure was completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A2: age at time of the event: unknown / not provided.A3: gender: unknown / not provided.A4: patient weight: unknown / not provided.E1: reporter name: unknown / not provided.G4: premarket identification pma/510(k) #: 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) spb10, (impl tapered sp 3.7mm 10m m octagon) for evaluation.Visual evaluation was performed, the returned implant, bundle mount have no signs of use.The devices were returned outside of its original packaging / vials.Additionally, the inner vial was returned incomplete.Therefore, the reported complaint is non-verifiable.Device history record (dhr) review was completed for the subject lot number 2120023245.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 2120023245 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : disengaged.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 reported 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 10M 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: 22369424
• Report Number: 0002023141-2025-01793
• Device Sequence Number: 4413844
• Product Code: DZE
• UDI-Device Identifier: 00889024017177
• UDI-Public: (01)00889024017177(17)291119(10)2120023245
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: SPB10
• Device Lot Number: 2120023245
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/06/2025
• 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: 07/01/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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