MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,6.0MM,13MM,MTX; DENTAL IMPLANT

Model Number	TSVM6B13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown / not provided.B3: date of event unknown / not provided.E1: last/given name unknown / not provided.G4: additional pma/510(k) number ¿k101880.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the site at tooth location #30 has a fractured implant.It was found in x-ray and assumed it was the screw, but it was the implant instead.The implant was removed and the patient will return for future placement.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.Zimvie received one (1) implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone / tissue attached to external threads.The implant was severely damaged likely due to the removal process.Fracture at the collar identified.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number: 63659781.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: 63659781 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is 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, 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.

• Brand Name: IMP,TSV,MCOL MG,6.0MM,13MM,MTX
• 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 ; 5617766700
• MDR Report Key: 16952903
• Report Number: 0002023141-2023-01375
• Device Sequence Number: 7012885
• Product Code: DZE
• UDI-Device Identifier: 00889024019690
• UDI-Public: (01)00889024019690(17)220531(10)63659781
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 11/06/2023

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: Other
• Device Expiration Date: 05/30/2022
• Device Model Number: TSVM6B13
• Device Catalogue Number: TSVM6B13
• Device Lot Number: 63659781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic