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	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Pma/510k: k943604.
Event or Problem Description
It was reported that the implant at tooth site # unknown was unable to disengage implant from mount, another implant was placed.Additional appointment required: none reported.Symptoms as a result of the event: none reported.
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 signs of wear from use about the threads and tines.The mount and implant could not be disengaged when functionally tested.No pre-existing conditions were noted on the per.The reported product was located on an unknown tooth site and removed the same day as placement.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 2019070447.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 (2019070447) for similar event and no other complaint was identified.Based on the available information, device malfunction has occurred and the reported event was confirmed.
Event or Problem Description
No further event information available at the time of this report.

• 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: 11205928
• Report Number: 0002023141-2021-00123
• Device Sequence Number: 14585779
• Product Code: DZE
• UDI-Device Identifier: 00889024013124
• UDI-Public: (01)00889024013124(17)241003(10)2019070447(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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2021

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: 10/03/2024
• Device Model Number: 1989
• Device Catalogue Number: 1989
• Device Lot Number: 2019070447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 04/30/2021; 05/24/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 05/05/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention