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

Catalog Number	XIITP4310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: patient weight unknown / not provided.E1: reporter last name 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 that the implants at tooth site #3 and #4 were removed due to neurological problems.
Event or Problem Description
It was reported that during implant insertion, clinician did not penetrate the nerve and/or nerve canal.The implant was not placed too close to the nerve canal.Additional information provided on description of the neurological problems.Patient stated she started to experience headaches, loss of balance, affected vision, hot/warm feelings that emanate from her neck/ear on right side.
Additional Manufacturer Narrative
It was reported that the implants at sites three (3) & four (4) were removed.The patient reported that shortly after having the implants placed, they experienced neurological problems and requested the implants be removed.The patient was a smoker.The patient was grafted.Patients bone density was unknown.The event date was 08-mar-2021.Additional information was obtained via email on 17-apr-2024.It was reported that there wasn¿t nerve or nerve canal damage.In addition, the implant wasn¿t placed near the nerve canal.The clinician explained that the patient experienced headaches, loss of balance, affected vision, hot/warm feelings that emanate from her neck/ear on right side.Zimvie received one (1) xiitp4310, (osseotite tapered certain prevail implant 4/3 x 10mm) for evaluation.Visual evaluation was performed, the implant had signs of use, with bone / tissue attached to external threads.No damage identified or signs of malfunction that would have contributed to the event.Measurements match drawing.No allegations against the abutment returned, and no malfunction was identified.Dhr review was completed for the subject lot number 2021010496.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 2021010496 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz, the most likely root cause determined from the investigation was inadequate treatment planning and patient condition.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.The following sections have been updated: b4: date of this report.D9: device availability.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 4/3 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: 19057161
• Report Number: 0001038806-2024-00683
• Device Sequence Number: 6030653
• Product Code: DZE
• UDI-Device Identifier: 00844868022114
• UDI-Public: (01)00844868022114(17)260125(10)2021010496
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2024

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: Other
• Device Expiration Date: 01/24/2026
• Device Catalogue Number: XIITP4310
• Device Lot Number: 2021010496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/07/2024
• Supplement Report FDA Received Date: 05/10/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic