MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 4.8MM 8MM OCTAGON; DENTAL IMPLANT

Catalog Number	SPWB8
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number(b)(4).A4: patient weight: unknown / not provided g4: premarket identification: k011245|k002188.
Event or Problem Description
It was reported that the mount was stuck in the implant, and it was impossible to separate them.Procedure completed with another implant at tooth site #46.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) spwb8, (impl tapered sp 4.8mm 8mm octagon) for evaluation.Visual evaluation / functional test was performed, the devices could not be separated from each other during a functional testing.Device history record (dhr) review was completed for the subject lot number 2120018925.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 2120018925 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 material selection of the implant and/or fmt was not adequate to withstand recommended torque values for placement/seating.Therefore, based on the available information, a device malfunction did occur.The summary of the inspection results.The reported event is 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL TAPERED SP 4.8MM 8MM 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: 20707147
• Report Number: 0002023141-2024-03735
• Device Sequence Number: 12814776
• Product Code: DZE
• UDI-Device Identifier: 00889024017597
• UDI-Public: (01)00889024017597(17)290901(10)2120018925
• 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
• 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): 03/24/2025

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: SPWB8
• Device Lot Number: 2120018925
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2024
• 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: 11/18/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2024
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic