MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MTX 3.75 MM 10 MM; DENTAL IMPLANT

Model Number	1980
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Pma/510(k) number: k943604.
Event or Problem Description
It was reported that the implant loss integration with bone loss and perforated the sinus.Pain was reported as a result of the event.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes.' h3: device evaluated by manufacturer: change ¿no' to 'yes.'* one (1) impl twist mtx 3.75 mm 10 mm (1980) was returned for investigation (image attached in complaint).Visual evaluation of the as returned product identified minor signs of use.Implant matched prints where measured using caliper 1831, due (b)(6) 2022.No malfunction was noticed during product evaluation that will contribute to the event.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on tooth # 16 (fdi) and was used for approximately 1 year, 4 months.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: spline twist¿ implants fu 8962 rev 3 - 09/19.Dhr review: dhr review was completed for the subject lot number (63647682).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 (63647682) for similar events and no other complaint was identified.Review completed utilizing keywords: 'perforated sinus' & ' loss of integration bone loss.' post market trend review: august post market trending was reviewed and there were no actionable events or corrective actions for the reported events (perforated sinus & loss of integration bone loss) or product (1980).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL TWIST MTX 3.75 MM 10 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: 14425181
• Report Number: 0002023141-2022-01198
• Device Sequence Number: 5487643
• Product Code: DZE
• UDI-Device Identifier: 00889024013032
• UDI-Public: (01)00889024013032(17)220430(10)63647682
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K013494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: 1980
• Device Catalogue Number: 1980
• Device Lot Number: 63647682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/25/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female