MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM; DENTAL IMPLANT

Catalog Number	TSV6B11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant in site 30 was removed due to infection.Came for post op appointment with complaints of swelling, pain, tenderness to adjacent teeth.Implant was removed and the site debrided.Noted abscess, pain and inflammation.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.E1: initial reporter¿s title is not provided / unknown.G4: additional 510(k) number is k013227.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.

• Brand Name: IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19002665
• Report Number: 0002023141-2024-00971
• Device Sequence Number: 8434577
• Product Code: DZE
• UDI-Device Identifier: 00889024019386
• UDI-Public: (01)00889024019386(17)280610(10)1268523
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2024

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 Catalogue Number: TSV6B11
• Device Lot Number: 1268523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2023
• 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: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic