MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM; DENTAL IMPLANT

Model Number TSVWB11

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Premarket identification pma/510(k) number k013227.No product returned.

Event Description

Doctor reported that during preparation for a surgery, she found out that there is no implant in the inner vial.After opening the vial, she saw there was only the plastic that holds the implant.The procedure was completed with another implant.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).One impl tapered scr-v sbm 4.7mm 4.5mm 11.5mm (tsvwb11) was returned for investigation.Visual inspection of the as returned product identified that the vial is empty of the implant and its components.The cap is noted to already be opened.The device is not noted to be used in a patient.The reported event could not be recreated due to the nature of the dental device and event (packaging issue).Review of appropriate documentation: documents reviewed: 4869 rev 9-10/19; product packaging; page 2-3.Dhr review was completed for the subject lot number 63949261.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 was 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 (63949261) for similar event and no other complaint was identified.October post market trending was reviewed and there were no actionable events or corrective actions for the reported event (missing components) or product (tsvwb11).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.As the packaging was already opened, the circumstances of device delivery could not be recreated.

Event Description

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

• Brand Name: IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10499205
• MDR Text Key: 206122709
• Report Number: 0002023141-2020-01376
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00889024020054
• UDI-Public: (01)00889024020054(17)230228(10)63949261(241)TSVWB11
• Combination Product (y/n): N
• PMA/PMN Number: K061410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSVWB11
• Device Catalogue Number: TSVWB11
• Device Lot Number: 63949261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1