MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1MM,DUAL SEL,HA; DENTAL IMPLANT

Catalog Number	TSV4H11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A1: patient identifier (b)(6).A4: patient weight unknown / not provided.It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient experienced a bone fracture at implant tooth site # 24.At the time of the flap elevation for adjacent implant placement, an extensive apical bone loss was found.Therefore, the implant was removed.
Additional Manufacturer Narrative
Zimvie complaint number cmp-(b)(4).The following fields have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h10: additional narrative zimvie received one (1) tsv4h11, (imp, tsv,4.1mm, dual sel, ha) for evaluation.Visual evaluation was performed, no damaged/malfunction identified that would contribute to the reported event.Implant matched prints where measured.Dhr review was completed for the subject lot number 1252640.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 1252640 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: medical: bone fracture the customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was inadequate treatment planning and patient factors.Therefore, based on the available information, a device malfunction did not occur.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) tsv4h11, (imp,tsv,4.1mm,dual sel,ha) for evaluation.Visual evaluation was performed, no damaged/malfunction identified that would contribute to the reported event.Implant matched prints where measured.Dhr review was completed for the subject lot number 1252640.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 1252640 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : bone fracture.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was inadequate treatment planning and patient factors.Refer to attached summary investigation for bone loss.Therefore, based on the available information, a device malfunction did not occur.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.Similar complaints for bone loss related problems have been previously investigated.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.Furthermore, the probability of manufacturing or design defects that might lead to bone loss escaping the available detections is remote and almost nonexistent.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP,TSV,4.1MM,DUAL SEL,HA
• 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: 18853359
• Report Number: 0002023141-2024-00614
• Device Sequence Number: 12586350
• Product Code: DZE
• UDI-Device Identifier: 00889024019317
• UDI-Public: (01)00889024019317(17)270417(10)1252640
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K072589
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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: Health Professional
• Device Catalogue Number: TSV4H11
• Device Lot Number: 1252640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/06/2024
• Supplement Report FDA Received Date: 08/06/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic