MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 3.75 MM 1 0 MM; DENTAL IMPLANT

Model Number	1989
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight: not provided.Additional pma/510(k) number: k943604.Device not returned.
Event or Problem Description
It was reported that during implant placement the implant fixture mount was unable to disengage from the implant (1989).Implant was removed and another implant was placed instead.Tooth location 15.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One impl twist mp-1 3.75 mm 1 0 mm (1989) was returned for investigation.Visual inspection of the as returned product identified minimal signs of wear about the implant threads, mount, and tines.No pre-existing conditions were noted on the per.The reported product was located on tooth # 15 (universal) and was removed the same day.The reported event could not be recreated when the returned product was functionally tested.The mount was able to disengage with little effort using normal hand tools.Dhr review was completed for the subject lot number 2019060326.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 (2019060326) 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 (stuck components) or product (1989).Therefore, based on the available information, device malfunction has not occurred and the reported event was unconfirmed.The following sections have been updated: g7: checked "follow-up.".

• Brand Name: IMPL TWIST MP-1 3.75 MM 1 0 MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10524907
• Report Number: 0002023141-2020-01418
• Device Sequence Number: 14248841
• Product Code: DZE
• UDI-Device Identifier: 00889024013124
• UDI-Public: (01)00889024013124(17)240823(10)2019060326(241)1989-LZ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 08/23/2024
• Device Model Number: 1989
• Device Catalogue Number: 1989
• Device Lot Number: 2019060326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR