MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 5.0 MM 8 MM; DENTAL IMPLANT

Model Number	1993
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant body cannot be removed from the fixture mount.The implant at tooth location #4 was removed and another implant was placed.
Additional Manufacturer Narrative
(b)(4).Weight unknown / not provided.Additional pma/510(k) number ¿ k962106.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4310 and 4315.One (1) impl twist mp-1 5.0 mm 8 mm (1993) was returned for investigation.Visual evaluation of the as returned product identified the implant with mount attached along with one opened outer box/packaging.Signs of use.Based on the evaluation, device malfunction has not occurred.Additionally, there are no existing nonconformance/capa/hhe/d/ie/product holds against the reported product that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review was completed for the subject lot number (2019090494).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 (2019090494) was performed for similar event using keyword does not disengage/release and no other similar complaint was identified.The reported event could not be recreated when the returned product was functionally tested.The mount was able to disengage with little effort using in-house hand tools.As per the risk management file, the potential cause for the reported event is due to excessive insertion torque.However, the probable causes are not applicable to the reported event since the device malfunction did not occur and the event is unconfirmed through visual and physical inspection.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: IMPL TWIST MP-1 5.0 MM 8 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: 12975684
• Report Number: 0002023141-2021-03572
• Device Sequence Number: 20041314
• Product Code: DZE
• UDI-Device Identifier: 00889024013162
• UDI-Public: (01)00889024013162(17)240911(10)2019090494
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 1993
• Device Catalogue Number: 1993
• Device Lot Number: 2019090494
• 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: 11/25/2021
• Supplement Date Received by Manufacturer: 06/05/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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 Age: 72 YR
• Patient Sex: Male