MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE 2 IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	XFOS411
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that during implant surgery everything went ok, as the implant is for external connection, the implant was correctly placed with the mount into the patients mouth.Cover screw placed.Second phase went ok as well, scanbody placed ( from another manufacturer ipd).When trying to place the healing abutment (from ipd as well) the healing abutment does not seat.Doctor alleges that the implant connection is damaged as it happen the same for another patient same reference and lot number.
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.D9: device availability.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.It was reported that that during implant surgery everything went ok, as the implant is for external connection, the implant was correctly placed with the mount into the patient¿s mouth.Cover screw placed.Second phase went ok as well, scan body placed (from another manufacturer ipd).When trying to place the healing abutment (from ipd as well) the healing abutment does not seat.Doctor alleges that the implant connection is damaged as it happened for the same for another patient same reference and lot number.Zimvie did not receive one (1) xfos411, (osseotite 2 implant 4 x 11.5mm) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 2022040350.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 2022040350 for similar events and 1 other relevant complaint(s) 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 the torque or speed applied during placement/seating exceeded recommended value.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.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 2 IMPLANT 4 X 11.5MM
• 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: 18336986
• Report Number: 0001038806-2023-02450
• Device Sequence Number: 6739816
• Product Code: DZE
• UDI-Device Identifier: 00844868023852
• UDI-Public: (01)00844868023852(17)270505(10)2022040350
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111216
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: XFOS411
• Device Lot Number: 2022040350
• Was Device Available for Evaluation?: No
• 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: 12/15/2023
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic