MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 3.75 X 11.5MM; DENTAL IMPLANT

Catalog Number	OSS311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that the oss311 implant fractured.The tip was removed but could not be recovered.If possible, please investigate and confirm the recovered part.It will be re-buried at a later date.
Additional Manufacturer Narrative
Zimvie received one (1) oss311, (osseotite implant 3.75 x 11.5mm) for evaluation.Visual evaluation was performed, there was the implant had signs of use.The implant was fractured at the body.The bottom portion was not returned.Dhr review was completed for the subject lot number: 2018092107.No deviations or non-conformance's, 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: 2018092107 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: fracture: implant¿.The customer did submit images for the reported event.The image was a fractured implant in a sterile peel pak.Based on the investigation and risk management file review as per rm-00053-haz, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, a device malfunction did occur.The implant was fractured at the body.The bottom portion of the implant was not returned.The reported event was confirmed.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 IMPLANT 3.75 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19939958
• Report Number: 0001038806-2024-01712
• Device Sequence Number: 7433120
• Product Code: DZE
• UDI-Device Identifier: 00844868013112
• UDI-Public: (01)00844868013112(17)231010(10)2018092107(241)OSS311
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/09/2023
• Device Catalogue Number: OSS311
• Device Lot Number: 2018092107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/08/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic