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	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown/not provided.Gender unknown/not provided.Patient weight unknown/not provided.Pma/510k: k943604.Device manufacturer date unknown/not provided.
Event or Problem Description
It was reported that the fixture mount and screw could not be removed from the spline twist.The doctor stopped using the implant and placed another product in the clinic.Tooth location not reported.
Additional Manufacturer Narrative
One impl twist mp-1 3.75 mm 1 0 mm (1989), fixture mount and packaging were returned for investigation.Visual evaluation of the as returned products identified signs of wear threads due to usage.The devices were engaged.Functional testing to recreate the reported event was performed.The devices were able to disengage under application of excessive force.Therefore, the reported event was confirmed.No pre-existing conditions were reported.The reported devices were being placed in an unknown tooth site when the incident occurred.X-ray/picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot (2019091341) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019091341) for similar events (complaint category keywords: functional: does not disengage/release) and 1 other complaint was identified under (b)(4).Based on the available information and functional testing, device malfunction did occur 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: 11638223
• Report Number: 0002023141-2021-00900
• Device Sequence Number: 3356287
• Product Code: DZE
• UDI-Device Identifier: 00889024013124
• UDI-Public: (01)00889024013124(17)240924(10)2019091341
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 09/24/2024
• Device Model Number: 1989
• Device Catalogue Number: 1989
• Device Lot Number: 2019091341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 08/26/2021
• 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