MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7, 13, MTXF, MG,HA; DENTAL IMPLANT

Model Number	TSVTWH13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).(b)(6).Pma/510(k) number: k133339.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant was received with the mount unattached.The clinician reattached the mount to the implant and attempted to place the implant.While transporting implant to the patient's mouth the implant fell to the floor from mount.
Additional Manufacturer Narrative
One (1) imp, tsv, 4.7, 13, mtxf, mg, ha (tsvtwh13) was returned for investigation.Visual evaluation of the as returned product identified minor signs of use.Functional testing to recreate the reported event; verified the implant & mount engages/disengages as intended.No malfunction.Additionally, the customer initially reported that the mount and the implant were disengaged from each other.However, that event could not be verified, as the customer also reported re-attaching the mount to the implant, in an attempt to place the implant during surgery, then later allegedly, the customer claimed the implant fell while transporting the implant to the patient mouth.The coob is non-verifiable as the conditions of the device when delivered could not be verified.Pre-existing patient factors, x-ray, tooth locations are not relevant to the reported event.The customer did not provide any pictures.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1250012).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 was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1250012) for similar events and no other complaint was identified.February post market trending was reviewed and there were no actionable events or corrective actions for the reported event (disengaged) or product (tsvtwh13).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction could not be verified, and the reported event was non-verifiable with the information provided.Additionally, the customer initially reported that the mount and the implant were disengaged from each other.However, that event could not be verified, as the customer also reported re-attaching the mount to the implant, in an attempt to place the implant during surgery, then later allegedly, the customer claimed the implant fell while transporting the implant to the patient mouth.The coob is non-verifiable.The following sections have been updated: h3: changed "no" to "yes.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 4.7, 13, MTXF, 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: 16250732
• Report Number: 0002023141-2023-00346
• Device Sequence Number: 6605819
• Product Code: DZE
• UDI-Device Identifier: 00889024344365
• UDI-Public: (01)00889024344365(17)270117(10)1250012
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/18/2023

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 Model Number: TSVTWH13
• Device Catalogue Number: TSVTWH13
• Device Lot Number: 1250012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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 Sex: Unknown