MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 11.5 MM; DENTAL IMPLANT

Catalog Number	XIITP6511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown / not provided.G4: additional pma/510(k) number ¿ k011028 | k013227.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the doctor tried to place the implant at tooth location #18, however a possible buccal fracture was noted because the torque was good then it wasn't.The implant was unable to be placed and the socket was grafted.The patient will return to the clinic in four (4) months to place a new implant.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, and apparent markings likely from removal.The implant had debris on its internal and external threads.No damage identified or signs of malfunction that would have contributed to the reported events.The implant outer dimension match drawing.Functional testing to recreate the reported event could not be performed due to the nature of the device & events.Dhr review was completed for the subject lot number 2022080131.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022080131 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are patient factors, inadequate treatment planning.Therefore, based on the available information, 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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 11.5 MM
• 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: 19143179
• Report Number: 0001038806-2024-00771
• Device Sequence Number: 15443920
• Product Code: DZE
• UDI-Device Identifier: 00844868022213
• UDI-Public: (01)00844868022213(17)270913(10)2022080131
• 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
• 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
• Report Date (Section B): 08/27/2024

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: Health Professional
• Device Catalogue Number: XIITP6511
• Device Lot Number: 2022080131
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2024
• 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: 04/19/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic