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

Model Number	OSS311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Patient id not provided.Patient age not provided.Patient weight not provided.
Event or Problem Description
It was reported that the implant was removed due to becoming fractured at the site.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated: b4: date of this report; b5: describe event or problem; d4: udi not available; d4: expiration date ; g3: date received by the manufacturer; h1: type of report, follow-up number; h2: follow up type; h3: device evaluated by manufacturer: change ¿no' to 'yes'; h4: device manufacture; h6: evaluation codes; h10: additional narrative.An implant was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and bone with fracture at the threads.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported device location is unknown and was used for approximately 2 years.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev j - 2022/08 information identified: 'warnings' 'precautions' 'potential adverse events'.Dhr review: dhr review was completed for the subject lot number (2019072151).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2019072151) for similar event and no other complaint was identified.Review completed utilizing keywords: fracture implant post market trend review: dec post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did occur and the reported event was confirmed.

• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15396314
• Report Number: 0001038806-2022-01409
• Device Sequence Number: 5006590
• Product Code: DZE
• UDI-Device Identifier: 00844868013112
• UDI-Public: (01)00844868013112(17)240903(10)2019072151
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 09/03/2024
• Device Model Number: OSS311
• Device Catalogue Number: OSS311
• Device Lot Number: 2019072151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose