MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1,16,MTX,MG; DENTAL IMPLANT

Model Number	TSVT4B16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient id not provided.Patient weight not provided.
Event or Problem Description
It was reported that at time of implant placement, patient bit down on handpiece causing a lack of primary stability.Patient will return for a new implant.
Additional Manufacturer Narrative
Product evaluation: one tapered screw-vent implant and mount was returned for investigation.Visual evaluation of the as returned products identified bone/blood residue around the external threads due to usage but no apparent signs of malfunction.The device could not be functionally tested for the reported events/failure (inability to place and bone fracture).However, measurements of the implant were taken using a caliper (id: (b)(6); cal due: (b)(6) 2022).Through dimensional analysis and comparison to drawings, the devices were determined to be within design specifications.Pre-existing patient condition noted on the per was moderate bone density ¿ type ii.X-ray & picture evaluation: x-ray or picture images were not provided.Therefore, the reported event could not be verified.Review of appropriate documentation: per the applicable ifu, it is stated that improper techniques can cause bone loss, patient injury, pain and implant failure.Dhr review: dhr review for the lot had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lots were inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number for similar events (complaint category keywords: medical: unable to place implant into osteotomy & bone fracture) and 1 other complaint was identified under (b)(4).Post market trending review: october post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information and dimensional analysis, device malfunction did not occur.Additionally, the reported events could not be verified since they are medical conditions and no x-ray or pictorial evidence was available (patient anatomical condition and details of events were unknown).Sections updated: b4: date of this report.G3: date additional information/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.Section corrected: b5: event description (to include report of bone fracture).
Event or Problem Description
It was reported that at time of implant placement, patient bit down on handpiece causing a lack of primary stability and a bone fracture.Patient will return for a new implant.

• Brand Name: IMP,TSV,4.1,16,MTX,MG
• 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: 12406895
• Report Number: 0002023141-2021-02386
• Device Sequence Number: 5292695
• Product Code: DZE
• UDI-Device Identifier: 00889024019850
• UDI-Public: (01)00889024019850(17)251124(10)1240768
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: Health Professional
• Device Expiration Date: 11/24/2025
• Device Model Number: TSVT4B16
• Device Catalogue Number: TSVT4B16
• Device Lot Number: 1240768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• 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: 08/05/2021
• Supplement Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male