MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 15MM; DENTAL IMPLANT

Catalog Number	XIITP5415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.D1: brand name unknown / not provided.D4: lot/serial # unknown / not provided.D4: device expiration date unknown / not provided.D4: device udi number unknown / not provided.D6b: explant date unknown / not provided.G4: pma/510(k) number unknown / not provided.H4: device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that the implants at tooth sites #11 was removed due to pain.(b)(6)2023 implants #4,6,9,11 & 13 were placed for fixed bridge.On (b)(6)2023 patient complained of pain, implant #11 was removed and implant #12 placed.Patient stated he "cant live with screws in head" requested implant to be removed.Symptoms as a result of the event: pain & headache.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated:.
Event or Problem Description
It was reported that the implants at tooth sites #11 was removed due to pain.(b)(6) 2023 implants (b)(6) were placed for fixed bridge.On 3/27, 2023 patient complained of pain, implant #(b)(6) was removed and implant #12 placed.Patient stated he "cant live with screws in head" requested implant to be removed.Symptoms as a result of the event: pain & headache.Customer called back and reported that the implant at tooth #11 was xiitp5415 removed on (b)(6) 2023 due to pain.
Additional Manufacturer Narrative
Zimvie received one (1) xiitp5415, (osseotite tapered certain prevail implant 5/4 x 15mm) for evaluation.Visual evaluation / functional evaluation of the as returned product identified signs of use but no apparent signs of malfunction.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2021060113.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 2021060113 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿pain¿.The customer did/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 missing or confusing instructions for use and inadequate treatment planning.Therefore, based on the available information, device malfunction did not occur, and the reported event could not be verified as the exact details of event were unknown/unverifiable.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.The following sections have been updated: h3: changed "no" to "yes".
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 15MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17402089
• Report Number: 0002023141-2023-02045
• Device Sequence Number: 12234222
• Product Code: DZE
• UDI-Device Identifier: 00844868022183
• UDI-Public: (01)00844868022183(17)260618(10)2021060113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2024

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: 06/17/2026
• Device Catalogue Number: XIITP5415
• Device Lot Number: 2021060113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2023
• 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; Not provided
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/29/2023; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic