MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM; DENTAL IMPLANT

Model Number TSVB11

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that when the product was opened, there was no implant.Procedure was completed with other implant.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Premarket identification |k013227.

Manufacturer Narrative

Zimvie complaint number (b)(4).The following sections have been updated: b4: date of this report; b5: describe event or problem; d4: lot number; d4: expiration date and udi; g3: date received by the manufacturer; g4: pma/510(k): k013227; h1: type of report, follow-up number; h2: follow up type; h4: device manufacture date; h10: additional narrative.Lot number updated.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Zimvie complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.One empty outer vial for impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm (tsvb11) was returned for investigation.Visual evaluation of the as returned outer vial identified the tamper seal was already broken.The implant packaging was not received.The coob is non-verifiable.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing patient factors, x-ray, tooth locations are not relevant to the reported event.The customer did provide one (1) picture.Further evaluation of the customer's picture identified the implant packaging with a different lot number.Review of appropriate documentation: documents reviewed: ¿instructions for use for tapered screw-vent®, advent® and trabecular metal¿ implants¿ 4869 rev 9 -10/19.Information identified: 'precautions' 'warnings' 'adverse effects'.Dhr review: dhr review was completed for the subject lot number (1255247).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.Upon review of the dhr, packaging images have been attached to further verify the conformance of the packaging for the reported device.Complaint history review: complaint history review was performed for the reported lot number (1255247) for similar events and two (2) other complaints were identified, ((b)(4) & (b)(4)).Review completed utilizing keywords: 'incorrect component quantity.'.Post market trending review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event (incorrect component quantity) or product (tsvb11).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, the packaging malfunction could not be verified, and the reported event was non-verifiable.The circumstances of the device delivery could not be recreated.Additionally, the alleged coob could not be verified.

Event Description

No further event information is available at the time of this report.

• Brand Name: IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
• Type of Device: 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: 16397823
• MDR Text Key: 309888823
• Report Number: 0002023141-2023-00581
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00889024019515
• UDI-Public: (01)00889024019515(17)270601(10)1255247
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K061410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSVB11
• Device Catalogue Number: TSVB11
• Device Lot Number: 1255247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1