MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1MM,DUAL SEL,HA; DENTAL IMPLANT

Model Number	TSV4H11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Summary investigation.
Event or Problem Description
It was reported that the patient presented with acute pain.The implant was subsequently removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified signs of usage.No significant damage was identified.The implant analyzed and found to be according to the drawing specifications.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.The patient had type iv (low) bone density.The reported device was located on tooth #19 and was placed approximately for 47 days.X-ray or picture image was not provided.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complainant reported that the patient presented with acute pain.The implant was subsequently removed.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes'.H3: device evaluated by manufacturer: change ¿no' to 'yes'.The following sections have been corrected: h3: device evaluated by manufacturer; should have been 'device evaluation anticipated, but not yet begun (02)'.

• Brand Name: IMP,TSV,4.1MM,DUAL SEL,HA
• 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: 12525083
• Report Number: 0002023141-2021-02658
• Device Sequence Number: 19948457
• Product Code: DZE
• UDI-Device Identifier: 00889024019317
• UDI-Public: (01)00889024019317(17)260503(10)1242540
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K072589
• 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): 02/22/2022

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: 05/03/2026
• Device Model Number: TSV4H11
• Device Catalogue Number: TSV4H11
• Device Lot Number: 1242540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female