MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED IMPLANT 4 X 13MM; DENTAL IMPLANT

Catalog Number	NT413
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during second stage surgery cover screw was removed and healing abutment was placed, it did not screw properly and fractured at the screw of the abutment.Doctor tried to remove fragment of abutment screw with the proper tool, when it was not possible, implant was removed.Doctor reported deformation of internal thread of implant at tooth site 14.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided a2: age at time of the event: unknown / not provided a3: gender: unknown / not provided a4: patient weight: unknown / not provided d4: additional device information: unknown / not provided d10: concomitant medical product: unknown biomet healing abutment, lot: unknown h4: device manufacturer date: unknown / not provided.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) the following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) nt413, (osseotitel tapered implant 4 x 13mm) for evaluation.Visual evaluation was performed, the implant had signs of use with bone debris on its external threads.The implants platform was damaged.The implant had a fractured screw partially drilled out.Dhr review was completed for the subject lot number 2023020453.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 2023020453 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : damaged drive feature.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error.Therefore, based on the available information, a device malfunction did occur.There implants drive feature was damaged.The reported event was confirmed.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.

• Brand Name: OSSEOTITE¿ TAPERED IMPLANT 4 X 13MM
• 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: 20578460
• Report Number: 0001038806-2024-02501
• Device Sequence Number: 15615861
• Product Code: DZE
• UDI-Device Identifier: 00844868012030
• UDI-Public: (01)00844868012030(17)280220(10)2023020453
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• 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): 01/19/2025

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 Catalogue Number: NT413
• Device Lot Number: 2023020453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2024
• 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: 10/31/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic