MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 3.75 MM 1 1.5 MM; DENTAL IMPLANT

Model Number	2120
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant body cannot be removed from the fixture mount.The implant was removed and another implant was placed.Tooth site # 30.
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 1.5 mm (2120) and mount and packaging were returned for investigation.Visual evaluation of the as returned product identified signs of use.Pre-existing condition as noted on the per was unknown.The implant had been placed on tooth #30 (universal) and was removed the same day.The returned product was functionally tested.The mount was not able to disengage from the implant.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 2020080603.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 by lot number (2020080603) was performed for similar event and no other similar complaint identified.Based on the available information, device malfunction has occurred and the reported event was confirmed.

• Brand Name: IMPL TWIST MP-1 3.75 MM 1 1.5 MM
• Common Device Name: 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: 12562711
• Report Number: 0002023141-2021-02746
• Device Sequence Number: 13731493
• Product Code: DZE
• UDI-Device Identifier: 00889024013261
• UDI-Public: (01)00889024013261(17)250901(10)2020080603
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 09/01/2025
• Device Model Number: 2120
• Device Catalogue Number: 2120
• Device Lot Number: 2020080603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male