MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SP 3.7MM 10M M OCTAGON; DENTAL IMPLANT

Catalog Number	SPB10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mount did not detached from the implants at tooth sites #4 - 7.Implants were removed.Patient referred pain and discomfort.Procedure was completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.D10: concomitant medical product: spb8, impl tapered sp 3.7mm 8mm octagon, lot: 63386526.G4: premarket identification pma/510(k) #: k011245|k002188.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b1: report type.B4: date of this report.B5: describe event or problem.D1: brand name unknown / provided.D4: additional device information.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer? h4: device manufacturer date.H6: event problem codes.H10: additional narrative.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) spb10, impl tapered sp 3.7mm 10m m octagon for evaluation.Visual inspection was performed.The implant has signs of use with bone debris on its external threads.The mount wouldn¿t disengage from the implant.Dhr review was completed for the subject lot number 2019101660.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 2019101660 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: does not disengage/release¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was probably user caused.Therefore, based on the available information, a device malfunction did occur.The mount was observed to be stuck to the implant.The reported even was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23714435
• Report Number: 0001038806-2025-03545
• Device Sequence Number: 21078185
• Product Code: DZE
• UDI-Device Identifier: 00889024017177
• UDI-Public: (01)00889024017177(17)241023(10)2019101660
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K082639
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/23/2024
• Device Catalogue Number: SPB10
• Device Lot Number: 2019101660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/04/2025; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic