MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM; DENTAL IMPLANT

Model Number TSVWB10

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).Pma/510(k) number: k011028, k013227.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that when placing the implant on tooth site #8, the buccal plate broke out.Stability could not be obtained, and the implant was removed.No harm to the patient.

Manufacturer Narrative

This report is being submitted to report additional information.The product was returned, the reported event was non-verifiable with the information provided.Based on the evaluation, device malfunction has not occurred.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable events or corrective actions for the reported events or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the device was within specifications and conforming when it left zimvie.Dhr review was completed for the subject lot number.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 was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be identified.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.A summary investigation has been completed for lack of primary stability events that do not allege a deficiency with the implant and identified that the reported event is likely due to biological factors which have an adverse effect on implant stability or is related to surgical technique and insertion torque.Due to a wide range of external factors (non-design/ non-manufacturing related), identifying a definitive root cause is generally not possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

Event Description

No additional or corrected information to report.

• Brand Name: IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
• Type of Device: 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: 16397655
• MDR Text Key: 309766510
• Report Number: 0002023141-2023-00518
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00889024020047
• UDI-Public: (01)00889024020047(17)270727(10)1256673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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
• Device Operator: Health Professional
• Device Model Number: TSVWB10
• Device Catalogue Number: TSVWB10
• Device Lot Number: 1256673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male