MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SP 4.8MM 10M M OCTAGON; DENTAL IMPLANT

Catalog Number	SPWB10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) e1: reporter email address unknown / not provided.G4: premarket identification k011245/k002188.
Event or Problem Description
It was reported that the abutment/mount was stuck in the implant at tooth site # 47, so the doctor had to remove it and place another implant.No impact on the patient was reported.
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: 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) spwb10, (impl tapered sp 4.8mm 10m m octagon) for evaluation.Visual evaluation of the as returned devices identified the implant and bundle mount with minor signs of use.The implant and the mount were stuck together and couldn¿t be disengaged during a functional test.The dhr was requested; however, an electronic copy is not available for review.The investigation will be reopened and updated upon any new or additional information provided to this complaint.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Complaint history review was performed for the reported lot number 2120030501 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿does not disengage/release¿ based on the investigation and risk management file review, the most likely root causes determined from the investigation are incorrect techniques used during implant placement - customer error.Therefore, based on the available information and functional testing, a device malfunction did occur.The reported event was confirmed with all the available information.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.

• Brand Name: IMPL TAPERED SP 4.8MM 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: 23554197
• Report Number: 0001038806-2025-03149
• Device Sequence Number: 9828955
• Product Code: DZE
• UDI-Device Identifier: 00889024017566
• UDI-Public: (01)00889024017566(17)300407(10)2120030501
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 01/05/2026

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: SPWB10
• Device Lot Number: 2120030501
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/21/2025
• 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
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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 Age: 69 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic