MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 10MM; DENTAL IMPLANT

Catalog Number	XIITP5410
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number cmp (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported mechanical failure of implant #13, unable to restore #13.Per indicated: symptoms as a result of the event: none indicates.Surgical/medical intervention required for permanent damage: not indicated.Additional appointment required: none indicated.On (b)(6) 2024 complaint coordinator called the customer and customer confirm placement date (b)(6) 2020, implant was removed for infection and mechanical failure.Antibiotics was given for the infection.Customer could not confirm if this event is the implant that was mangled (stating mangled implant=mechanical failure).
Additional Manufacturer Narrative
Zimvie received one (1) xiitp5410, (osseotite® tapered certain® prevail® implant 5/4 x 10mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, slight wear; however, no apparent damage or malfunction to the implant was identified that would cause or contribute to the reported events.Markings are likely due to the removal process.The implant engaged an in-house screw and abutment as intended, during a functional test.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2019072138.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 2019072138 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿functional other¿ and ¿infection¿.The customer did not submit images for the reported events.Based on the investigation and risk management file review as per rmf rm-00053-haz rev.12, the most likely root cause determined from the investigation is improper techniques used, and patient factors.Refer to attached summary investigation for ¿infection¿.Therefore, based on the available information, and functional testing a device malfunction did not occur.The reported events were non-verifiable with all the available information.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 implant infection have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.While non-conformances were identified for some lots during manufacturing record reviews, the documented disposition actions for each did not suggest the likely release of non-conforming product.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.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 10MM
• 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: 20932520
• Report Number: 0001038806-2024-02916
• Device Sequence Number: 5129528
• Product Code: DZE
• UDI-Device Identifier: 00844868022152
• UDI-Public: (01)00844868022152(17)240823(10)2019072138
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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 Expiration Date: 08/22/2024
• Device Catalogue Number: XIITP5410
• Device Lot Number: 2019072138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• 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: 12/14/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic