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

Catalog Number	TSV6H11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #19 was removed due to pain.Implant placed and patient returned 4 days later with pain and tingling.Patient has some sensation intra and extra orally.Discussed with patient that could just be from inflammation compressing on the nerve.Discussed leaving the implant for a few days to see if there is any improvement.Patient chose to remove implant due to pain.Removed implant and placed puros graft.Upon removal, noted there was a bony floor and inferior alveolar nerve was not exposed.Patient has not returned for implant.Symptoms as a result of the event: pain and inflammation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: last name unknown / not provided.G4: additional pma/510(k) number k013227.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) tsv6h11, (impl tapered scr-v ha 6 mm 5.7 mm 11.5 mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent minor bone/tissue attached to external threads.The implant was identified as reported however, no apparent malfunction was identified with the implant that would contribute to the reported event.Implant matched prints where measured.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1260108.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1260108 for similar events and no other complaint was identified.Review completed utilizing keywords: "pain".The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rmf rm-00541-haz rev.4, the most likely root cause determined from the investigation is inadequate treatment planning.Therefore, based on the available information, a device malfunction did not occur.The reported event was non-verifiable with all the available information.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: IMPL TAPERED SCR-V HA 6MM 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: 21631454
• Report Number: 0002023141-2025-00727
• Device Sequence Number: 9372035
• Product Code: DZE
• UDI-Device Identifier: 00889024019461
• UDI-Public: (01)00889024019461(17)280122(10)1260108
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 06/24/2025

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: TSV6H11
• Device Lot Number: 1260108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic