MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1MM,SBM,16; DENTAL IMPLANT

Catalog Number	TSV4B16
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported stuck mount.Unable to remove the mount.Procedure was finish with another implant.Tooth site # 25.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) tsv4b16, (imp,tsv,4.1mm,sbm,16) for evaluation.Visual evaluation of the as returned devices identified the implant & bundle mount attached to each other with signs of use.The mount wouldn¿t disengage from the implant during a physical / functional test.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1267046.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 1267046 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿does not disengage/release¿ the customer did not submit images for the reported event.Ifu review: documents reviewed: instructions for use ¿ tapered screw-vent® and trabecular metal¿ implants - 4869 rev.9-10/19.Information identified: "breakage." based on the investigation and risk management file review as per rmf rm-00541-haz rev.3, the most likely root causes determined from the investigation are customer error - excessive torque applied.Therefore, based on the available information, 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: IMP,TSV,4.1MM,SBM,16
• 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: 18264067
• Report Number: 0002023141-2023-03497
• Device Sequence Number: 7890555
• Product Code: DZE
• UDI-Device Identifier: 00889024019256
• UDI-Public: (01)00889024019256(17)280426(10)1267046
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K072589
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: TSV4B16
• Device Lot Number: 1267046
• 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
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic