MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 16MM; DENTAL IMPLANT

Catalog Number	TSVH16
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).G4: additional pma/510(k) number ¿ k011028 | k013227.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient experienced an implant fractured at tooth #6 when the dentist was tightening the crown.Therefore, the implant was removed.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.H6: evaluation method codes were added: 10, 4109, 4111, 3331 h6: evaluation result code was added: 3252 h6: evaluation conclusions code was added: 4310 dhr review was completed for the subject lot number 63217329.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 63217329 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.9-10/19.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 material selection of implant inadequate (unable to withstand occlusal forces or long term loading) - 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.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.
Event or Problem Description
No additional information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.
Event or Problem Description
It was reported the implant and the screw fractured at tooth #6 when the dentist was tightening the crown.Therefore, the implant with the stuck broken screw was removed.

• Brand Name: IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 16MM
• 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: 17742245
• Report Number: 0002023141-2023-02542
• Device Sequence Number: 4085624
• Product Code: DZE
• UDI-Device Identifier: 00889024019591
• UDI-Public: (01)00889024019591(17)201130(10)63217329
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2016
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/18/2024

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: Health Professional
• Device Expiration Date: 11/29/2020
• Device Catalogue Number: TSVH16
• Device Lot Number: 63217329
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2023
• 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; Not provided
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 02/16/2024; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2015
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic