MAUDE Adverse Event Report: BIOMET 3I TSX IMPLANT, 3.1MMD, 13MML; DENTAL IMPLANT

Catalog Number	TSX31B13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Sinus Perforation (2277)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of event unknown / not provided.D4: additional device information unknown / not provided.D4: unique identifier (udi) number not available.D9: device availability unknown / not provided.H4: device manufacturer date unknown / not provided.
Event or Problem Description
Doctor reported perforation of vestibular window at tooth site 12.Another implant was placed to complete the procedure.
Event or Problem Description
Additional information was obtained via email on (b)(6) 2024, the clinician reported that the event wasn¿t a sinus perforation but a vestibular perforation in the anterior sector.It was also noted that despite the presence of a surgical guide and a cone-beam computed tomography (cbct), bone density and volume do not did not allow him to position a 3.1 x 13 implant but a 3.1 x 11 implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).It was reported that perforation of vestibular window at tooth site 12.Another implant was placed to complete the procedure.Patient history and bone density unknown.Additional information was obtained via email on 20-jun-2024, the clinician reported that the event wasn¿t a sinus perforation but a vestibular perforation in the anterior sector.It was also noted that despite the presence of a surgical guide and a cone-beam computed tomography (cbct), bone density and volume do not did not allow me to position a 3.1 x 13 implant but a 3.1 x 11 implant.Zimvie received one (1) tsx31b13, (tsx implant, 3.1mmd, 13mml) for evaluation.Visual evaluation was performed, the implant had signs of use with markings from removal.No damage identified or signs of malfunction that would contribute to the event.Measurements match drawing.Dhr review was completed for the subject lot number 1272339.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 1272339 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : perforated sinus.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 damage to the implant was identified.The reported event was non-verifiable with all the available information provided.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.H3 other text : investigation completed.

• Brand Name: TSX IMPLANT, 3.1MMD, 13MML
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 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: 19151963
• Report Number: 0001038806-2024-00790
• Device Sequence Number: 18251200
• Product Code: DZE
• UDI-Device Identifier: 00844868045014
• UDI-Public: (01)00844868045014(17)250927(10)1272339
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K220978
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: Lay User/Patient
• Device Expiration Date: 09/26/2025
• Device Catalogue Number: TSX31B13
• Device Lot Number: 1272339
• 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: 04/22/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic