MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7,10,MTX,MC,MG,HA; DENTAL IMPLANT

Model Number	TSVMWH10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Pma/510: k133339.
Event or Problem Description
It was reported that dr.Indicated malfunction.The implant body cannot be removed from the fixture mount.The implant was removed and another implant was placed.Tooth site # 29.
Additional Manufacturer Narrative
Imp, tsv, 4.7,10,mtx,mc,mg,ha (tsvmwh10) were returned for investigation.Visual evaluation of the as returned product identified both implants with signs of use.The coob could not be verified since, the device was used.Functional testing to recreate the reported event; verified the implant was unable to disengage/release from the mount.A pre-existing condition noted on the per was high bone density (type i).The reported device was located on tooth # 29 (universal) and were used, placed and removed on the same day.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1241578).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1241578) for similar events and one (1) other complaint was identified (b)(4).Aug post market trending was reviewed and there were no actionable events or corrective actions for the reported event.No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, devices malfunction did occur and the reported event was confirmed.The coob could not be verified since, the device was used.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 4.7,10,MTX,MC,MG,HA
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14141307
• Report Number: 0002023141-2022-00934
• Device Sequence Number: 6245852
• Product Code: DZE
• UDI-Device Identifier: 00889024344143
• UDI-Public: (01)00889024344143(17)260216(10)1241578
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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 Expiration Date: 02/16/2026
• Device Model Number: TSVMWH10
• Device Catalogue Number: TSVMWH10
• Device Lot Number: 1241578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: 43 YR
• Patient Sex: Male