MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,3.7,16,MTX,MG; DENTAL IMPLANT

Catalog Number	TSVTB16
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint: (b)(4).E1: initial reporter¿s title is not provided / unknown.
Event or Problem Description
It was reported that the implant in tooth site #12 was internally damaged during clinical procedure.Procedure was completed with another implant.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.Zimvie received one implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, bone debris on its external and internal threads.The drive feature was not damaged.The implant's internal threads have bone debris stuck to them.An in-house screw engaged and disengaged as intended during a functional test.Dhr review was completed for the subject lot number.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 for similar events and no other complaint was identified.A definitive root cause could not be determined since the device malfunction did not occur, and the reported event has been unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, and functional testing a device malfunction did not occur.The reported event was unconfirmed 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.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: IMP,TSV,3.7,16,MTX,MG
• 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: 18915448
• Report Number: 0002023141-2024-00757
• Device Sequence Number: 15176596
• Product Code: DZE
• UDI-Device Identifier: 00889024019959
• UDI-Public: (01)00889024019959(17)270803(10)1257042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: Lay User/Patient
• Device Catalogue Number: TSVTB16
• Device Lot Number: 1257042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• 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: 03/15/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic