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

Catalog Number	OSS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not proided.
Event or Problem Description
It was reported implant fracture in the cervical third at tooth site 26.Abutment screw is intact.Patient referred pain and was rescheduled for removal of the remaining part of the implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) oss411, (osseotite® implant 4 x 11.5mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, and apparent bone / tissue attached to external threads.The implant was fractured at the collar region.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.This complaint refers to the specific device being investigated for this complaint record.Device history record (dhr) review was completed for the subject lot number 2016010214.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 2016010214 for similar events and no other complaint was identified.Review completed utilizing keywords: fracture implant.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are missing or confusing instructions for use, clinician selects implant that is unable to resist long-term occlusal loading, clinician places implant in a patient with patient factors (e.G.Bruxism) incompatible with long-term osseointegration of implant.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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 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 ; 5617766700
• MDR Report Key: 17123327
• Report Number: 0001038806-2023-01144
• Device Sequence Number: 6458250
• Product Code: DZE
• UDI-Device Identifier: 00844868013181
• UDI-Public: (01)00844868013181(17)210120(10)2016010214
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2023

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: Other
• Device Expiration Date: 01/19/2021
• Device Catalogue Number: OSS411
• Device Lot Number: 2016010214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic