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

Catalog Number	SPB10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that both mounts cannot be disengaged from implants.Another implant was placed in the procedure.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event: unknown / not provided.A4: patient weight: unknown / not provided.D10: concomitant medical product: spb10, impl tapered sp 3.7mm 10m m octagon, lot: 2023061098.G4: premarket identification: 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: 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 and functional test were performed, the implant had signs of use.The mount wouldn¿t disengage from the implant.Device history record (dhr) review was completed for the subject lot number 2023061098.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 2023061098 for similar events and 1 other relevant complaint(s) 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 the torque applied during placement/seating exceeded recommended value.Therefore, based on the available information, a device malfunction did occur.The bundled mount wouldn¿t release from the implant.The reported event was confirmed.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.

• 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: 21502192
• Report Number: 0002023141-2025-00515
• Device Sequence Number: 4591177
• Product Code: DZE
• UDI-Device Identifier: 00889024017177
• UDI-Public: (01)00889024017177(17)280628(10)2023061098
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/20/2025

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: Health Professional
• Device Catalogue Number: SPB10
• Device Lot Number: 2023061098
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2025
• 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: 03/03/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic