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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Patient weight unknown / not provided.Pma/510k: k943604.
Event or Problem Description
It was reported that the healing cap can't be screwed.The implant was removed and another implant was placed.Tooth site #15.
Event or Problem Description
During the investigation process, after visual inspection, fractured/broken spline on implant was also identified and captured in the investigation.
Additional Manufacturer Narrative
One impl twist mp-1 3.75 mm 1 0 mm (1989) was returned for investigation.Visual evaluation of the as returned products identified the implant and cover screw were not fully attached with signs of usage on both implant and cover screw/cap.Damaged threads identified on the cover screw and implant spline identified broken as well.After separating the cover screw, functional testing to recreate the reported event could be performed and the cover screw/cap could not be fully threaded into the implant.Patient pre-existing condition as noted on the per was type ii (moderate) bone density.The devices were located on tooth site #15 (universal) and removed same day.X-ray or picture was not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 2019070450.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 (2019070450) was performed for similar event and no other similar complaint was identified.Based on the available information, device malfunction has occurred and the reported event was confirmed.Additionally, after visual inspection, fractured/broken spline also identified and captured in the investigation.Furthermore, coob could not be verified with the information available.The following sections have been updated: h3: changed "no" to "yes".

• 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
• 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: 12338829
• Report Number: 0002023141-2021-02197
• Device Sequence Number: 14141785
• Product Code: DZE
• UDI-Device Identifier: 00889024013124
• UDI-Public: (01)00889024013124(17)241004(10)2019070450
• 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): 01/31/2022

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: 10/04/2024
• Device Model Number: 1989
• Device Catalogue Number: 1989
• Device Lot Number: 2019070450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• 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: 07/30/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• 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: Female