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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: last name unknown / not provided.G4: k013227.
Event or Problem Description
It was reported implant fractured, tooth 30.
Additional Manufacturer Narrative
Zimvie received one (1) tsv6h11, (impl tapered scr-v ha 6mm 5.7mm 11.5mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use and apparent bone debris on external threads.Damage from the removal process was identified.The implant's collar was fractured.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 63756411.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 63756411 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Ifu review: documents reviewed: instructions for use ¿ tapered screw-vent® and trabecular metal¿ implants - 4869 rev.(b)(6) 2019.Information identified: "breakage" page 2.Based on the investigation and risk management file review as per rmf rm-00541-haz rev.3, the most likely root causes determined from the investigation are missing or confusing instructions for use, clinician places implant in a patient with patient factors (e.G.Bruxism) incompatible with long-term osseointegration of implant, clinician selects implant that is unable to resist long-term occlusal loading.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed 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.The following sections have been updated:.
Event or Problem Description
No further event information available at the time of this report.

• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17402070
• Report Number: 0002023141-2023-02044
• Device Sequence Number: 14912266
• Product Code: DZE
• UDI-Device Identifier: 00889024019461
• UDI-Public: (01)00889024019461(17)220831(10)63756411
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/30/2022
• Device Catalogue Number: TSV6H11
• Device Lot Number: 63756411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• 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: 07/26/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic