MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 6MM 5.7MM 13MM; DENTAL IMPLANT

Model Number	TSV6H13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional pma/510(k) number ¿ k011028, k013227.Infection: a summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
It was reported by the customer that the implant was removed due to infection.Patient had a fistula and drainage around the implant area.Placed on antibiotics and it was not resolving and therefore the implant was removed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4) a device history record 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.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes; type of investigation h10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL TAPERED SCR-V HA 6MM 5.7MM 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12135954
• Report Number: 0002023141-2021-01689
• Device Sequence Number: 4130988
• Product Code: DZE
• UDI-Device Identifier: 00889024019478
• UDI-Public: (01)00889024019478(17)241021(10)1227234
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 10/21/2024
• Device Model Number: TSV6H13
• Device Catalogue Number: TSV6H13
• Device Lot Number: 1227234
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 11/02/2021
• 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: 44 YR
• Patient Weight: 64