MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 3.75 MM 1 3 MM; DENTAL IMPLANT

Catalog Number 1990

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age: not provided.Patient weight: not provided.Initial reporter fax number: not provided.

Event Description

It was reported that during procedure after implant (1990) was placed, doctor tried to attach the healing screw left in the implant vial and the healing screw was not firmly attached to the implant vial lid package and screw fell to the floor.Doctor confirmed used the same healing screw that fell to complete the procedure.Tooth location 7.

Event Description

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

Manufacturer Narrative

The impl twist mp-1 3.75 mm 1 3 mm (1990) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information.The reported event could not be recreated due to the nature of the dental device and event (packaging event).The customer has not provided additional pictures or x-ray images of the product.Dhr review was completed for the subject lot number 2018110517.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.It is noted that all post sterilization packaging that was inspected contained all material.Complaint history review was performed for the reported lot number (2018110517) for similar event and no other complaint was identified.June post market trending was reviewed and there were no actionable events or corrective actions for the reported event (package components disassembled) or product (1990).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.The following sections have been updated: b4: date of this report.D4: unique identifier (udi) number.D4: expiration date.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H6: entered evaluation codes.H10: added manufacturer narrative.

• Brand Name: IMPL TWIST MP-1 3.75 MM 1 3 MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10175276
• MDR Text Key: 195783333
• Report Number: 0002023141-2020-00919
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K013494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2024
• Device Catalogue Number: 1990
• Device Lot Number: 2018110517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1