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 Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that after placing the implant, the healing screw stopped in the middle and could not be installed until the end as it got stuck.The implant was removed and replaced with a new one in the same procedure.
Event or Problem Description
There is no update to the original complaint description provided.
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 implant was returned with the mount, healing screw, and opened packaging.No apparent malfunction with the returned devices.Functional testing to recreate the reported event verified the healing screw seated to the implant as intended.A pre-existing condition noted on the per was moderate bone density (type ii).The reported device was located on tooth # 30 (universal) and 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 (2019060330).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2019060330) for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release.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.Sections updated: b4: date of this report d9: device availability and product return date g3: date investigation results were received g6: type of report and follow up number h2: follow up type h3: device evaluated h6: adverse event problem codes h10: manufacturer's narrative.

• 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: 13192248
• Report Number: 0002023141-2022-00044
• Device Sequence Number: 5199359
• Product Code: DZE
• UDI-Device Identifier: 00889024013124
• UDI-Public: (01)00889024013124(17)240911(10)2019060330
• 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): 06/28/2022

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: 09/11/2024
• Device Model Number: 1989
• Device Catalogue Number: 1989
• Device Lot Number: 2019060330
• 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: 12/14/2021
• Supplement Date Received by Manufacturer: 06/25/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female