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	Insufficient Information (4580)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional 510(k) number is k943604.
Event or Problem Description
It was reported that at the time of placement, the mount was stuck to the implant and was unable to be removed.The procedure was completed using another implant.
Additional Manufacturer Narrative
One (1) impl twist mp-1 3.75 mm 1 0 mm (1989) was returned for investigation.Visual evaluation of the as returned product identified the device outside of original packaging.During functional testing, the device was easily disengaged.Some signs of use but no apparent malfunctions.A pre-existing condition noted on the per was unknown bone density type.The reported device was placed and removed on the same day.The customer did not provide any pictures or x-rays review of appropriate documentation: documents reviewed: 8962 rev 3 - 09/19; warnings; page 1.Dhr review: dhr review was completed for the subject lot number (2020120995).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 numbers were inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review by lot number (2020120995) was performed for similar event using keyword does not disengage/release and no other similar complaint was identified.Post market trending review: april post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (1989).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction has not occurred and the reported event was unconfirmed.
Event or Problem Description
There is no update to the original complaint description provided.

• 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: 13158581
• Report Number: 0002023141-2022-00011
• Device Sequence Number: 5311662
• Product Code: DZE
• UDI-Device Identifier: 00889024013124
• UDI-Public: (01)00889024013124(17)260419(10)2020120995
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 04/19/2026
• Device Model Number: 1989
• Device Catalogue Number: 1989
• Device Lot Number: 2020120995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male